GXP Good Practice Guidelines Jobs in Bengaluru
111 Jobs Found
Medical Review Physician 1
Clinchoice
Medical Review Physician 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks. Key Responsibilities Medical Review & Safety Assessment Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality. Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness. Support triage activities and determine seriousness and relatedness across assigned products. Product & Process Expertise Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases. Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs). Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms. Collaboration & Training Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies. Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge. Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently. Compliance & Quality Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines. Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards. Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary. Candidate Profile Education: MBBS or MD is required. Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs. Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements. Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint). Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team. Be part of a high-impact team contributing to global drug safety. Collaborate across a wide range of therapeutic areas and product portfolios. Develop and grow within a supportive, knowledge-driven work environment. Engage in continuous learning and professional development in a critical area of healthcare. Qualification : MBBS or MD is required
Conversational Ai Lead Or Architect
Avaamo
Conversational AI Lead / Architect Location: Bangalore | Employment Type: Full-time About the Role We are looking for a skilled and experienced Conversational AI Lead/Architect to join our team at Avaamo. In this role, you will be responsible for designing, developing, and implementing cutting-edge Conversational AI solutions. As a subject matter expert, you'll work closely with IT managers, business teams, and customers to understand their requirements and deliver high-impact solutions that enhance the Avaamo platform. Responsibilities Lead the design, coding, and implementation of Avaamo s Conversational AI products, ensuring solutions meet both technical and business needs. Collaborate with IT managers and business stakeholders to gather requirements and translate them into actionable technical solutions. Drive the implementation of solutions using Conversational Design principles and best practices. Develop, deploy, and maintain customized extensions to the Avaamo platform tailored to specific customer requirements. Provide technical guidance and training sessions to partner and customer development teams, ensuring smooth onboarding and ongoing success. Evaluate reported defects and prioritize them for resolution, ensuring product quality and customer satisfaction. Travel to customer locations for on-site support, providing hands-on assistance and expertise as needed. Document best practices, implementation guidelines, and "how-to" guides to support customer and partner teams in leveraging Avaamo s products effectively. Requirements (Mandatory) 6+ years of strong programming experience in JavaScript, HTML, and CSS. Proven expertise in creating and consuming REST APIs and SOAP services. In-depth knowledge of web technologies and current industry trends. Solid understanding of security in web applications and services. At least 2 years of experience using Node.js, with a deep understanding of its architecture. Hands-on experience with Git and other version control systems. Experience deploying web applications on Linux servers in production environments. Familiarity with deployment processes and CI/CD tools. Exceptional communication skills, with the ability to work with both technical and non-technical teams. Minimum of 2 years of experience in client-facing roles, working closely with customers to deliver solutions. Good to Have Full-stack development experience, with expertise in UI/UX design or insights. Working knowledge of AI, ML, and NLP technologies. Experience with enterprise system integrations, such as MS Dynamics CRM, Salesforce, ServiceNow, and MS Active Directory. Experience implementing Single Sign-On (SSO) in web/mobile applications. Ability to quickly learn new technologies and manage small engineering teams. At Avaamo, we re redefining the future of Conversational AI. We specialize in creating advanced conversational interfaces that solve high-impact challenges for enterprises. Join our team and contribute to pioneering AI-driven technologies that are transforming how businesses engage with customers and employees.
Senior R&D Scientist Downstream
Danaher Corporation
Job Title: Senior R&D Scientist Downstream, Fast Trak Process Design & Validation Services Location: Bengaluru, India About the Role: We are seeking a Senior R&D Scientist Downstream to lead the technical development and execution of new or improved services aligned with our R&D strategic initiatives. This role focuses on downstream process development services and spans the full innovation cycle from defining specifications and designing solutions to validation and market launch support. You will work in close collaboration with R&D project managers and cross-functional teams to bring new bioprocess services to life. Key Responsibilities: Serve as the technical lead on innovation projects, working closely with R&D project managers and relevant departments to ensure successful project execution. Define and document technical specifications for new service and product developments based on customer and market requirements. Plan, execute, and report on technical studies, including risk assessments and experimental design, throughout various project stages. Lead and conduct verification and validation studies to ensure new services/products meet both technical and marketing requirements. Oversee lab setup and documentation in preparation for service commercialization. Ensure compliance with Environment, Health & Safety (EHS) standards and regulatory guidelines within laboratory operations. Qualifications: Bachelor s, Master s, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific discipline. Minimum of 5 years of hands-on experience leading and delivering technical projects in a scientific or bioprocessing environment. Proven ability to work independently, troubleshoot complex problems, and think creatively to develop practical solutions. Experience managing multiple projects in parallel, with strong organizational and time-management skills. Excellent communication, reporting, and presentation skills, with the ability to tailor information to both technical and non-technical stakeholders. Preferred Experience: Familiarity with aseptic laboratory techniques. Working knowledge of Good Laboratory Practice (GLP). Experience in upstream or downstream biotechnology unit operations. Qualification : Bachelors, Masters, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific discipline.
Grc Specialist
Locus
Job Title: GRC Specialist Location: Bangalore (On-site; full-time) About Locus: At Locus, we are redefining logistics decision-making with deep-tech solutions that drive efficiency, consistency, and transparency across industries like retail and FMCG/CPG. Founded in 2015 by Nishith Rastogi and Geet Garg, Locus has evolved from a women s safety geo-tracking app into a globally recognized logistics optimization platform. Our technology has empowered enterprises such as Unilever and Nestl to execute over a billion deliveries across 30+ countries. Guided by our commitment to innovation and sustainable growth, we transform complex supply chains into strategic growth enablers. Join us at Locus and be part of a team shaping the future of global logistics. Job Overview: About the Role Governance Risk and Compliance Specialist (GRC Specialist) We're looking for a candidate with 2-4 years of relevant experience. Key Responsibilities: Define, implement, and maintain the Information Security Management System (ISMS) and Privacy Information Management System (PIMS). Plan and execute periodic risk assessments. Work directly with the business units to facilitate risk assessment and risk management processes. Define, Review and Maintain the organizational information security policies, processes, procedures and control framework to ensure it is adequate to address the emerging risks due to changing environment, technology and legal requirements. Align customer and internal information security objectives to the ISMS and PIMS. Monitor and fulfill client contractual (MSA) information security and privacy obligations. Monitor and fulfill legal obligations related to protection of personal information across different jurisdictions like GDPR, CCPA. Prepare metrics based periodic reports and dashboards with support from the stakeholder functions for management review. Liaise with security vendors, suppliers, service providers and external resources for new security tools for improving security. Lead the Information Security audits / assessments / remediation and present key risks to the management. Perform the Third party Risk Assessment of Critical Vendors. Conduct Information Security and Privacy awareness and training programs for the employees as part of their induction and regular awareness. Oversee information security and privacy incident management process for incident reporting, containment, resolution and root cause analysis. Plan and coordinate BCP and DR tests. Setup guidelines for secure coding practices. Recommend security and privacy controls based on people, process and technology approach and industry best practices. Identifying solutions or writing automation scripts for solving regular tasks or optimizing processes. SOC Monitoring Activities such as. Firewall, Vulnerability, Inspector, Guarduty etc. Log Review, Incident Handling & Compliance adherence. Qualifications: Good understanding of information security compliance requirements like ISO27001, SOC2, CSA STAR and Privacy requirements like BS10012 & ISO27701. Good understanding of legal obligations towards protection of personal information across different jurisdictions like GDPR, CCPA, etc. Experience in creating and auditing security and privacy best practices and implementation of security and privacy principles across organization, to meet business goals along with customer and regulatory requirements. Experience implementing security and privacy controls for cloud platforms like AWS, Azure. Experienced in solving Audit and Regulatory Issues. Experience in auditing MDM, SSO solutions, AWS (Cloud Infra), Firewall, WAF, DLP etc. Good at solving information security compliance challenges by recommending solutions and best practices. Join Locus and become part of a visionary team that is redefining logistics through innovation and smart distribution. We provide competitive compensation, comprehensive benefits, and a collaborative environment where your expertise will drive both your growth and that of the organization. Locus is an equal opportunity employer dedicated to creating a diverse and inclusive workplace.
Product Designer
Locus
Job Title: Product Designer Location: Bangalore (On-site; full-time) About Locus: At Locus, we are redefining logistics decision-making with deep-tech solutions that drive efficiency, consistency, and transparency across industries like retail and FMCG/CPG. Founded in 2015 by Nishith Rastogi and Geet Garg, Locus has evolved from a women s safety geo-tracking app into a globally recognized logistics optimization platform. Our technology has empowered enterprises such as Unilever and Nestl to execute over a billion deliveries across 30+ countries. Guided by our commitment to innovation and sustainable growth, we transform complex supply chains into strategic growth enablers. Join us at Locus and be part of a team shaping the future of global logistics. Job Overview: As a Product Designer, you will work alongside a team of Product Designers, Product Managers and Developers to drive design research, ideation, and execution across all our product PODs Key Responsibilities: Be well versed and up to date on mobile and dashboard design patterns. Lead the design process from concept to final implementation, including user research, wireframing, prototyping, and visual design. Conduct user research to gather insights and validate design decisions. Collaborate with product managers and engineers to define and refine product requirements and ensure alignment with business goals. Usability test proposed solutions to refine the final product further. Create and maintain design documentation, including user flows, wireframes, prototypes, and high-fidelity visuals. Stay updated with industry trends, best practices, and emerging technologies to continuously improve design quality. Present design concepts and solutions to stakeholders, incorporating feedback and iterations as necessary. Qualifications: Prior experience or Degree in interaction design or related fields, such as user experience (UX) design, human-computer interaction (HCI) or graphic design. 2-4 years of experience in product design or a related role. A portfolio showcasing your design work and demonstrating your design process. Good understanding of the trends, best practices, and interface/interaction guidelines for Web, Android, and iOS platforms. Proficiency in Figma. Exceptional UX and UI design capabilities and a strong understanding of core design principles. A good understanding of design research and deriving behavioural analytics for design decisions. Good understanding of front-end UI/UX principles. Excellent communication and presentation skills, along with the ability to clearly articulate design decisions to their team. Obsessed with the tiniest details, ensuring designs are visually stunning and interactively groovy from start to finish. Join Locus and become part of a visionary team that is redefining logistics through innovation and smart distribution. We provide competitive compensation, comprehensive benefits, and a collaborative environment where your expertise will drive both your growth and that of the organization. Locus is an equal opportunity employer dedicated to creating a diverse and inclusive workplace.
Jr .executive Projects, Electrical & Mechanical Engineer
Aurigene Discovery Technologies
Key Responsibilities: Operation & Maintenance of HVAC Systems: Oversee and maintain HVAC systems, including AHU (Air Handling Units), BMS (Building Management System), chillers, and other associated components. Project Management: Plan, schedule, coordinate, and monitor assigned engineering modification projects. Assess project requirements, calculate timelines, and sequence project elements for optimal efficiency. Infrastructure Planning & Design: Lead the planning and design of new infrastructure requirements, specifically lab spaces, ensuring compliance with operational needs. Prepare BOQs (Bills of Quantities) and issue tenders to potential vendors, in coordination with the Supply Chain Management (SCM) team. Coordination with Contractors: Manage relationships with external contractors and service providers for executing new construction works, lab renovations, and facility enhancements. Compliance & Safety: Ensure adherence to safety, health, and environmental policies. Work alongside various stakeholders to maintain compliance with GMP standards and guidelines related to infrastructure and equipment. Development of SOPs: Develop, implement, and maintain Standard Operating Procedures (SOPs) to ensure compliance with GMP (Good Manufacturing Practices) principles for facility and equipment operations. Training & Development: Train the contract maintenance team on site operations, ensuring that all maintenance activities comply with safety and operational standards. Facility Maintenance & Upkeep: Oversee the maintenance of electrical and safety fixtures like UPS & batteries, panels, lighting fixtures, fire detection systems, fire hydrants, public address systems, and lifts, with minimal disruption to daily operations. Preventive & Breakdown Maintenance: Plan and implement preventive, periodical, and breakdown servicing of machinery and equipment, ensuring minimal downtime and efficient operation of facilities. Key Skills: HVAC System Management: Expertise in managing the operation and maintenance of HVAC systems, including high and low-side components such as AHUs, chillers, and BMS. Project Management: Ability to manage engineering projects from planning to execution, ensuring alignment with schedules and budgets. Proficient in preparing project schedules and monitoring progress. Infrastructure Design & Planning: Strong knowledge of infrastructure planning, especially in lab design, and expertise in preparing BOQs and issuing tenders. Contractor Coordination: Skilled at liaising with contractors and service providers for construction, renovation, and facility upgrades. Safety & Compliance Knowledge: Understanding of safety, health, and environmental policies, and expertise in adhering to GMP standards for infrastructure and equipment. Maintenance Planning: Expertise in developing and executing maintenance schedules for electrical and safety systems, ensuring operational continuity and minimal disruptions. SOP Development: Proficient in developing and implementing SOPs related to equipment and facility management in compliance with industry standards. Training & Team Management: Ability to train and manage maintenance teams, ensuring high standards of operation and maintenance. Competencies: Presentation & Communication Skills: Strong verbal and written communication abilities, capable of presenting complex information clearly and effectively to different stakeholders. GMP Standards & Procedures: Knowledge of Good Manufacturing Practices (GMP) and familiarity with industry standards and regulatory requirements for facility management and equipment maintenance. Interpersonal Skills: Ability to interact effectively with various stakeholders, including contractors, vendors, and internal teams. Team Player: Collaborative mindset, working well within cross-functional teams and with external partners to achieve common goals. Project Schedule Preparation & Management: Competence in preparing, updating, and managing project schedules, ensuring deadlines and milestones are met. Qualification : Diploma/ITI 4- 6 years experience.
Senior Phe Engineer
Mott Macdonald
Job Description : Be incharge for planning and design of all building services elements of the particular discipline. Be incharge for concept design based on evaluation for various options in coordination with architectural, structural input and in accordance with initial load estimates. Do design calculations and quantity estimation. Ensure all design work is carried out in accordance with Company s quality standard procedures. Ensure checking of all design output and seamless coordination between other sections/disciplines. Ensure the completeness of design deliverables within time limits Effective task management for design engineers and CAD Technicians. Share knowledge and experience to coach and develop junior staffs. Candidate Specification : Candidate should be B.E./B.Tech in Mechanical/Civil - Environment Engineering discipline. Have 8 to 12 years of experience in Public Health Engineering design and knowledge on inter-disciplines. Have experience in high rise buildings/shopping malls/hotels/metro projects etc., Have experience in design of internal/external water supply, sewerage and drainage ( storm water and surface water), Design of infrastructure water supply, sewerage, drainage and irrigation networks and checking of drawings and calculations. Preparation of reports such as Design basis, concept, schematic etc., and technical specifications. Be well versed in reviewing and checking of drawings and calculations. Have good awareness and knowledge in developing BOQ. Familiarity with local authority codes and regulations such as of local Municipality, water authority, drainage and sewerage department, environmental authority etc., of countries in which the candidate has job experience. Good knowledge of relevant international codes and regulations Knowledge in sustainable, green building design practices and rating guidelines. Handle design independently and lead a team of engineers and technicians/modellers. Have good oral and written communication skills and liaise with clients directly. Mott MacDonald is a leader in the adoption of BIM and therefore the use of REVIT/AECOsim would be highly regarded. We can offer (subject to Company s policy): - Agile and safe working environment - Competitive annual leave and sick leaves - Group incentive scheme - Group term life insurance, Workmen s compensation and Group medical insurance coverage - Short and Long-term Global employment opportunities - Global collaboration and knowledge sharing - Digital Innovation and Transformation Equality, diversity and inclusion We put equality, diversity and inclusion at the heart of our business, seeking to promote fair employment procedures and practices to ensure equal opportunities for all. We encourage individual expression in our workplace and are committed to creating an inclusive environment where everyone feels they have the opportunity to contribute. Agile working At Mott MacDonald, we believe it makes business sense for you and your manager to choose how you can work most effectively to meet your client, team and personal commitments. We embrace agility, flexibility and trust. Qualification : Candidate should be B.E./B.Tech in Mechanical/Civil - Environment Engineering discipline.
Wifi Automation Development Engineer
Intel Corporation
We are seeking a highly skilled and motivated Python and AWS Automation Engineer to join our dynamic team. In this role you will be responsible to automate infrastructure , deployment, and operational tasks using Python/C# and AWS services. Will play a critical part in developing and optimizing our cloud based analytics, streamlining workflows, and enhancing validation efficiency. As a key member of the automation team, expected to work closely with DevOps, engineering, and validation teams to implement scalable and reliable automation solutions for various WiFi features and validation processes. You will also be instrumental in integrating AWS services, creating efficient scripts, and ensuring seamless automation of cloud-based resources and services. Qualifications Key Responsibilities:* Design, develop, and maintain Python/C#-based automation scripts to process data to develop meaningful analytics for validation using AWS resources. * Leverage AWS services (such as Kubernetes) to automate processing for data analytics* Develop automation scripts and libraries for WiFi features* Collaborate with DevOps engineers to integrate automation processes into CI/CD pipelines (e.g., Jenkins)* Monitor and troubleshoot automation workflows to ensure they are running smoothly and efficiently.* Follow guidelines on best practices for cloud automation, scalability, security, and cost optimization in AWS.* Participate in the design and implementation of logging, monitoring, and alerting systems using AWS CloudWatch and other monitoring tools.* Develop and maintain detailed documentation for automation scripts, processes, and AWS configurations.* Ensure adherence to security best practices and compliance standards for cloud-based applications and infrastructure.Required Skills and Qualifications:* Proven hands on experience in Python and C# programming, with a focus on automation and cloud services.* Hands-on experience with AWS services, including Kubernetes* Strong understanding of cloud infrastructure and best practices for automating, scaling, and monitoring.* Experience in integrating automation with CI/CD pipelines and using tools like Jenkins* Knowledge of containerization and orchestration technologies such as Docker, Kubernetes, and ECS.* Hands on experience with automation using rest APIs and UI automation* Familiarity with version control systems (e.g., Git) and Gerrit* Strong problem-solving and troubleshooting skills.* Ability to work independently and collaborate effectively within a cross-functional team.* Excellent written and verbal communication skills.Domain Knowledge1. Hands on Experience in configuring/handling automation setups with different topologies2. WiFi Experience - Usage / Configuring of WiFi sniffer / Attenuator / Access Point will be helpful3. Fair understanding about test engineering skills, Validation Methodologies, Debugging techniquesSoft skills:1. Ability to work independently and collaborate effectively within a cross-functional team.2. Good written and verbal communication skills.3. Quick learning of new technologies4. Stakeholder management Inside this Business Group The Client Computing Group (CCG) is responsible for driving business strategy and product development for Intel's PC products and platforms, spanning form factors such as notebooks, desktops, 2 in 1s, all in ones. Working with our partners across the industry, we intend to deliver purposeful computing experiences that unlock people's potential - allowing each person use our products to focus, create and connect in ways that matter most to them. As the largest business unit at Intel, CCG is investing more heavily in the PC, ramping its capabilities even more aggressively, and designing the PC experience even more deliberately, including delivering a predictable cadence of leadership products. As a result, we are able to fuel innovation across Intel, providing an important source of IP and scale, as well as help the company deliver on its purpose of enriching the lives of every person on earth. Posting Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance. Benefits We offer a total compensation package that ranks among the best in the industry. It consists of competitive pay, stock, bonuses, as well as, benefit programs which include health, retirement, and vacation. Find more information about all of our Amazing Benefits here.It has come to our notice that some people have received fake job interview letters ostensibly issued by Intel, inviting them to attend interviews in Intel s offices for various positions and further requiring them to deposit money to be eligible for the interviews. We wish to bring to your notice that these letters are not issued by Intel or any of its authorized representatives. Hiring at Intel is based purely on merit and Intel does not ask or require candidates to deposit any money. We would urge people interested in working for Intel
Business Analyst
Tanla Platforms
Job Role Strong expertise in requirements management processes, including standard tools and techniques such as facilitated meetings, use cases, mapping documents, models and other requirements management tools. What you'll be responsible for? Strong expertise in requirements management processes, including standard tools and techniques such as facilitated meetings, use cases, mapping documents, models and other requirements management tools. Understanding the SOW and Preparing documentations (BRD, FSD, PRD) in conversational product platforms. Develop customer use cases, personas and scenarios and present solutions to clients. Should have experience working on Mid to large scale implementations. Create Use Cases Diagrams and Activity Diagrams for the stated work flows communicated by client s Work with the engineering teams to build and deploy solutions with optimal resources. Track the on-going implementation process and intimate the stakeholders for process deviation if any. Resolve day to day queries from development team based on knowledge of customer business. Scope and prioritize activities based on business and customer impact. Provide input to QA for creation of test plans and certification criteria. Assist and certify the UAT. Readiness to travel for short durations within India and outside. Qualification and other skills Bachelor s in engineering or Masters in Computer Applications or tech savvy MBA from good institute. What you'd have? 3-6 years experience in defining and managing core products or business applications, either through product management or equivalent activities. Worked in the cross functional environment for coordinating various project related aspects. Good knowledge and understanding of products in conversational platforms. Follow best practices which is under the guidelines set in CBAP (Good to have) Understanding ofVarious builders in NLP, AIML (Good to Have) Understanding of cloud-based systems along with knowledge of any domain such as Banking, Finance, Healthcare,Web/Social etc. Excellent written and verbal communication skills. Skilled in presentations and discussions with sales and engineering teams. Why join us? Impactful Work: Play a pivotal role in safeguarding Tanla's assets, data, and reputation in the industry. Tremendous Growth Opportunities: Be part of a rapidly growing company in the telecom and CPaaS space, with opportunities for professional development. Innovative Environment: Work alongside a world-class team in a challenging and fun environment, where innovation is celebrated. Tanla is an equal opportunity employer. Qualification : Bachelors in engineering or Masters in Computer Applications or tech savvy MBA from good institute.
Service Manager-veeva Quality Vault
Glaxosmithkline Plc
This is a new role created to provide service management excellence for Veeva Quality Vaults. The role will provide operational support for the L2/L3 support for the Quality Vault. Role is the backup for Service Owner to assist in managing Operational Activities. Job Purpose The Veeva Quality Service Manager lead the third-party team responsible for the Enterprise Veeva Quality Vault Support. User base for the Quality Vault is over 100k. Key Responsibilities Lead a team of high performing individuals who provide service management, oversight and interface with the strategic supplier and GSC Quality D&T. Oversee provision of all L2/L3 incident management, problem management, change management and fulfil the ITSM role. Serve as the primary operations escalation contact for Global Business Units Transform the ways of working from a project-based to a product-based organization, ensuring we maintain excellence in service management and operations. Analyse and review actual service performance against agreed SLA and OLA measures, including internal GSK metrics and external metrics with vendors (Veeva, Accenture) Lead continuous improvement initiates to enhance the SLA and OLA targets and metrics Provide regular reports on service performance and achievement to the service owner and governance boards Develop and maintain management processes and controls to ensure quality is maintained to meet business objectives Champion and promote service improvements to continually improve quality and customer satisfaction Maintain day to day responsibility for the ownership and resolution (including any referral or escalation as may be necessary) of significant service issues. Ensure the defined services capacity meets GSK business demand. Lead on ServiceNow CMDB currency, ensuring all is up to take and play a key role in change approvals. Oversee BAU Vault Loader Migrations, working with third party migration partners and Business teams to migrate content Manage IT Risks on behalf of the Veeva Quality Tech Team. Minimum Level of Job-Related Experience Required 8+ years of experience in Service Management 3+ years Veeva Vault experience, QMS/QualityDocs preferred Previous demonstrable excellent relationship building and communication skills ITIL or other Service Management qualifications Prior experience in Veeva migrations Veeva Platform Admin certifications
Statistical Programming Associate Director
Astrazeneca
Job Title: Statistical Programming Associate Director Career Level - E Introduction to role The Statistical Programming Associate Director is accountable for the quality, timely, and efficient delivery of project programming work and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the Programming discipline. As an expert within their own field, you will act as a specialist within cross-functional teams to deliver continuous improvement. Accountabilities Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function Leads implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverables and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Identifies opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences stakeholders by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Qualification : Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent
Senior .net Developer
In4velocity
Senior .NET Full-Stack Developer (5 8 Years) | Bangalore Location: Bangalore Experience Required: 5 to 8 Years Job Type: Full-time About the Role We are hiring a Senior .NET Full-Stack Developer to join our growing product development team in Bangalore. As part of this role, you will contribute to the development and enhancement of our award-winning Real Estate ERP platform In4Suite . You ll work across the full software development lifecycle from understanding requirements and designing robust architectures to building enterprise-level applications using the Microsoft .NET framework. This is a fantastic opportunity for developers who enjoy working with scalable enterprise software and want to be part of a high-impact, innovative team. Key Responsibilities Develop and maintain full-stack applications using ASP.NET, MVC, C#/VB.NET, ADO.NET. Design and implement complex modules and reusable components. Collaborate with UI/UX, QA, and other development teams for solution integration. Write efficient SQL queries and stored procedures for database operations. Interpret and create technical documentation: design specs, functional specs, and architecture documents. Troubleshoot, debug, and optimize code for performance and scalability. Follow best practices in code quality, testing, and software development methodologies. Ensure code compliance with coding standards, version control, and security guidelines. Provide timely updates on deliverables and contribute to project planning. Required Skills Strong application development experience using Microsoft .NET technologies. Hands-on experience with ASP.NET, MVC, C#/VB.NET, ADO.NET. Proficient in SQL Server including query writing, optimization, and stored procedures. Solid understanding of database concepts, Web Services (SOAP/REST), and XML. Good grasp of Object-Oriented Analysis and Design (OOAD), UML, and design patterns. Familiar with version control tools like Visual SourceSafe, Git, or CVS. Strong problem-solving and analytical skills with a high attention to detail. Preferred/Additional Skills Experience in ERP software development is a plus. Knowledge of Crystal Reports and ASP (Classic) is advantageous. Exposure to Build & Configuration Management tools and processes. Microsoft Certification (MCP/MCSD) is a strong plus. Educational Qualifications Bachelor s or Master s degree in Computer Science, Information Technology, or related discipline. 5 to 8 years of experience in product-based IT/software companies. Soft Skills & Team Culture Positive and proactive attitude toward learning and team collaboration. Strong communication skills both written and verbal. Commitment to shared goals and team success over individual recognition. A mindset focused on continuous improvement and innovation. Benefits at In4Velocity Flexible working hours for better work-life balance Access to continuous learning & development resources Comprehensive medical and insurance coverage A culture of teamwork, innovation, and excellence About In4Velocity Founded in 2004, In4Velocity is a leading enterprise software company dedicated to transforming the real estate, construction, and infrastructure sectors. Our flagship platform, In4Suite , is a comprehensive ERP solution that unifies sales, purchases, finance, construction, and project management into a single ecosystem. Trusted by clients across the globe, In4Suite is renowned for its end-to-end process automation, business intelligence, and intuitive design making it the go-to solution for real estate companies seeking digital transformation. Apply now and become a part of the In4Velocity innovation journey. Qualification : Bachelors or Masters degree in Computer Science, Information Technology, or related discipline.
Project Manager
Mphasis Limited
Project Manager - UX Designer Location:Bangalore Experience: 10 13 Years Job ID: 427120 Job Summary The UX Designer is responsible for designing user interfaces for web and mobile applications, ensuring a seamless user experience. The role demands collaboration with cross-functional teams, conducting user research, and maintaining design systems. The designer will create wireframes, prototypes, and high-fidelity designs that align with business goals and user needs. Years of Experience Needed At least 5-6 years of experience in UX/UI design with a total of 9 to 13 years of professional experience Portfolio showcasing design process, thinking, and execution Responsibilities Design User Interfaces Create wireframes, prototypes, and high-fidelity designs for web and mobile applications Develop and maintain design systems, style guides, and design standards Ensure consistency in design across all platforms User Experience (UX) Focus Conduct user research and usability testing to inform design decisions Collaborate with UX designers to create user-centered design solutions Analyze user feedback and iterate on designs accordingly Collaboration Work closely with product managers, developers, and other stakeholders to ensure design alignment with product goals Participate in design reviews and provide constructive feedback to peers Communicate design concepts and rationale effectively to both technical and non-technical teams Design Tools and Software Proficiency in Figma Photoshop and Illustrator skills are a plus MS Office Design Standards and Best Practices Stay updated with the latest design trends, best practices, and industry standards Contribute to the development of design guidelines and standards within the organization Project Management Manage multiple design projects simultaneously and meet deadlines Prioritize tasks and manage time efficiently to deliver high-quality designs Technical Skills Bachelor s degree in Graphic Design, Interaction Design, Human-Computer Interaction, or a related field Proven experience as a UX designer, with a strong portfolio showcasing successful projects Strong communication and collaboration skills Ability to work in an agile environment and adapt to changing project requirements Experience with usability testing and user research methodologies Other Skills We'd Appreciate Communication Skills: Ability to clearly communicate with other team members and stakeholders Collaborative Skills: Ability to work swiftly with various teams to achieve a common goal Time Management Skills: Commitment to on-time delivery in aggressive timelines Process Skills General SDLC processes Understanding of utilizing Agile and Scrum software development methodologies Skill in gathering and documenting user requirements and writing technical specifications Behavioral Skills Good attitude and quick learner Well-developed design, analytical, and problem-solving skills Strong oral and written communication skills Excellent team player, able to work with virtual teams Self-motivated and capable of working independently with minimal management supervision Certification Any certification in UX design Skill Breakdown Primary Competency: UX Design Primary Skill: UX Design (100%) Qualification : Bachelors degree in Graphic Design, Interaction Design, Human-Computer Interaction, or a related field
R&D Scientist Validation
Danaher Corporation
Job Title: R&D Scientist Validation, Fast Trak Process Design & Validation Services Location: Bengaluru, India About the Role: We are looking for an R&D Scientist Validation to support the design, execution, and validation of new or improved services as part of our R&D strategic plan. This role will focus on validation services across the bioprocessing portfolio and involves working from early concept development through testing and final implementation. The position also contributes to lab and facility setup and ensures all necessary documentation is in place for successful service launches. Key Responsibilities: Provide technical support on innovation and development projects, collaborating with R&D project managers and cross-functional teams to ensure timely and efficient delivery. Assist in defining technical requirements based on customer and market needs to guide new service/product development. Help plan, assess risks, execute, and document technical studies at different stages of project development. Design and execute verification and validation studies to confirm alignment of service/product outputs with technical and marketing specifications. Support laboratory operations and ensure adherence to Environment, Health & Safety (EHS) standards and regulatory compliance. Qualifications: Bachelor s, Master s, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field. Minimum of 3 years of experience supporting or leading technical projects within an R&D or bioprocessing environment. Strong problem-solving skills with a proactive, solution-oriented mindset and ability to work independently. Comfortable managing multiple projects simultaneously in a dynamic environment. Effective reporting and presentation skills, with the ability to tailor communication to various audiences. Preferred Experience: Familiarity with aseptic techniques and laboratory best practices. Working knowledge of Good Laboratory Practice (GLP) and scientific method principles. Qualification : Bachelors, Masters, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field.
Computer Scientist ( C++ )
Adobe
Our Company At Adobe, we're changing the world through digital experiences. We empower everyone from emerging artists to global brands with everything they need to design and deliver exceptional digital experiences. We're passionate about helping people create beautiful and powerful images, videos, and apps, and transform how companies interact with customers across every screen. We are on a mission to hire the very best talent and are committed to creating exceptional employee experiences where everyone is respected and has equal access to opportunity. New ideas can come from anywhere, and the next big idea could be yours! About the Team The Adobe Content Platform and Collaboration (ACPC) group is building a highly scalable and available content platform for Adobe s SaaS offerings, running on Amazon AWS. We're pushing the future of SaaS development by leveraging the latest technology stacks and design thinking. Our dedicated team of developers is building low-latency, cloud-scale foundational components such as Cache, Storage, Databases (SQL and NoSQL), Queuing, Pub/Sub, etc., to create a standard for developing, deploying, operating, and governing Adobe SaaS solutions, catering to millions of requests every day. What the Team Does: We love writing software. We love solving complex problems with simple, elegant designs. We build the platform using modern container orchestration technologies. We take a long-term architectural approach, ensuring that the platform supports both current and future needs of all Adobe services. We use best-in-class tools like GitHub, Slack, and any tools that help us stay productive. We are committed to adapting our processes to meet evolving needs. We trust each other to do our jobs exceptionally well. What You ll Do: Design and develop one or more services/components within the platform. Take responsibility for the full lifecycle of the project from user story to design, development, testing, documentation, and maintenance. As a senior team member, you will be responsible for setting code guidelines for the rest of the team. Adhere to standard software engineering practices. Collaborate in a highly dynamic, ever-evolving environment. Work with geographically distributed teams. Mentor junior team members to help them grow and improve. What You Need to Succeed: B.Tech/M.Tech in Computer Science (or equivalent experience) with an excellent academic record. 5 to 8 years of software development experience, primarily in backend systems. Proficiency in data structures and algorithms. Expertise in Java and related technologies (e.g., Spring Boot). Proven experience in designing, building, evolving, and maintaining large-scale, complex software projects. Self-starter with an ability and eagerness to learn new technologies and adapt quickly. Proven experience in developing scalable Cloud-based services on AWS/Azure. Strong programming and problem-solving skills. Good written and verbal communication skills. Strong team player who thrives in a collaborative environment. Experience with Agile development practices. Prior experience with MySQL, Redis, Cassandra, DynamoDB, Kafka will be a bonus. Pure Innovation: We celebrate critical thinkers who embrace challenges and aspire to innovate. Pure Growth: At Adobe, you have the space to grow and contribute meaningfully to something impactful. Pure Team: We build each other up and set aside egos for the greater good. Adobe is proud to be an Equal Employment Opportunity and affirmative action employer. We do not discriminate based on gender, race, color, ethnicity, national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other characteristic protected by law. Qualification : B. Tech and/or M. Tech in Computer Science with excellent academic record, or equivalent experience
Lead Software Engineer, Ui
Couchbase
Job Title: Senior UI Engineer Location: Bangalore, India About Couchbase: As industries race to embrace AI, traditional database solutions fall short of the increasing demands for flexibility, performance, and cost-efficiency. Couchbase is leading the way with Capella, the developer data platform for critical applications in today s AI world. By seamlessly uniting transactional, analytical, mobile, and AI workloads into a fully managed solution, Couchbase empowers developers and enterprises to build and scale applications with unmatched performance, scalability, and cost-effectiveness from cloud to edge. Trusted by over 30% of the Fortune 100, Couchbase is driving innovation, accelerating AI transformation, and redefining customer experiences. Join us on our mission! Job Overview: We are seeking a talented and experienced Senior UI Engineer to join our team. The ideal candidate will be a strong advocate for the user experience and have the expertise to rapidly convert UX designs into seamless, high-performing user interfaces that meet product specifications. Responsibilities: Collaborate closely with UX designers, product managers, and software engineers to understand project requirements and translate them into interactive, user-friendly interfaces. Design and develop responsive, visually appealing web applications and user interfaces using HTML, CSS, JavaScript, and React. Ensure technical feasibility of product requirements and UX designs, optimizing applications for maximum speed and scalability. Conduct code reviews and provide constructive feedback to foster continuous improvement within the team. Stay up-to-date with the latest trends, best practices, and emerging technologies in front-end development, and recommend their integration to improve product quality. Identify and resolve performance and compatibility issues across different browsers and platforms. Champion engineering best practices, standards, and guidelines within the team. Collaborate with backend developers to integrate front-end interfaces with server-side logic and APIs. Troubleshoot and debug issues, providing timely resolutions. Promote the writing of automated tests and adhere to testing best practices to ensure application quality. Requirements: Education: Bachelor's degree in Computer Science, Software Engineering, or a related field, or equivalent practical experience. Experience: 7-10 years of hands-on experience in building user interfaces for web applications. Technologies: Proficiency in front-end technologies such as TypeScript, Tailwind, React, and Angular. Performance Optimization: Solid understanding of web performance optimization techniques and best practices. Problem-Solving: Excellent problem-solving skills with the ability to troubleshoot complex issues. Collaboration: Strong communication and collaboration skills, with the ability to work effectively in a team-oriented environment. Leadership: Proven expertise in mentoring and guiding junior developers and advising leadership on the adoption of technologies that improve productivity, code quality, and maintainability. Preferred Qualifications: Experience designing products for software developers or databases is a plus. Familiarity with multi-cloud platforms and web applications, especially those used by database developers. Knowledge of Svelte component framework. Curious, adaptable, and willing to explore new challenges and continuously learn. Comfortable working in a fast-paced development and deployment environment. At Couchbase, we believe in empowering developers and architects to build modern applications that provide exceptional customer experiences. With our flexible, fast, and affordable cloud database platform, Capella, we offer organizations a unique edge in building scalable applications. We are proud to be trusted by over 30% of the Fortune 100 companies. Some of the benefits of working at Couchbase include: Generous Time Off Program: Flexibility to care for yourself and your family. Wellness Benefits: A variety of world-class medical plans, along with dental, vision, life insurance, and employee assistance programs. Financial Planning: RSU equity program, ESPP program, retirement plans, and business travel insurance. Career Growth: A "Be valued, Create value" approach to career development. Fun Perks: Ergonomic office setup, food and snacks for in-office employees, and more! Qualification : Bachelor's degree in Computer Science, Software Engineering, or a related field, or equivalent practical experience.
Senior Site Reliability Engineer
Couchbase
Job Title: Site Reliability Engineer (SRE) Cloud Platform & Production Pipeline Initiatives Location: Bangalore, India (Office-based role) About Couchbase: As industries race to embrace AI, traditional database solutions fall short of rising demands for versatility, performance, and affordability. Couchbase is leading the way with Capella, the developer data platform for critical applications in our AI-driven world. By uniting transactional, analytical, mobile, and AI workloads into a seamless, fully managed solution, Couchbase empowers developers and enterprises to build and scale applications with unmatched flexibility, performance, and cost-efficiency from cloud to edge. Trusted by over 30% of the Fortune 100, Couchbase is unlocking innovation, accelerating AI transformation, and redefining customer experiences. Come join our mission! Job Overview: As a Site Reliability Engineer (SRE), you will play a pivotal role in managing, optimizing, and maintaining Couchbase s cloud infrastructure for Capella, our Database as a Service (DBaaS) platform. You will be responsible for ensuring the reliability and performance of our cloud service while collaborating closely with engineering teams to improve deployment pipelines, security practices, and overall system health. You will work across cloud platforms and multiple tools to provide guidance, mentorship, and contribute to the strategic direction of cloud operations. Responsibilities: Infrastructure Management: Manage, monitor, and maintain the infrastructure for Capella to ensure reliable operations. Security & Compliance: Implement and manage cloud environments in accordance with company security guidelines, including vulnerability management, penetration testing, and compliance requirements (SOC 2, PCI-DSS, GDPR, HIPAA, etc.). CI/CD & Release Pipeline: Collaborate with engineering teams to optimize CI/CD processes, aiming for a highly resilient deployment strategy, ideally with zero downtime. Cloud Optimization: Stay up-to-date with new technologies and industry trends to continuously improve cloud platform architecture and meet the evolving needs of the business. Security Integration: Work with development teams to integrate security scanners within the DevOps lifecycle, enhancing security posture. Leadership & Mentorship: Provide guidance on architecture, code reviews, and technical feedback to improve service reliability, security, cost, and performance. Incident Management: Demonstrate exceptional problem-solving skills, proactively identifying and addressing potential issues before they affect business operations. Collaboration: Partner with development teams, application owners, and stakeholders to integrate best practices and ensure seamless service delivery. Requirements: Experience: 5+ years in Site Reliability Engineering (SRE), DevSecOps, or similar roles, with significant experience working in public cloud environments. Programming & Scripting: Proficiency in languages such as Go, Python, Java, or Ruby. Linux Expertise: High proficiency with Linux operating systems. Kubernetes Management: Experience in managing and maintaining Kubernetes clusters (both self-managed and managed platforms like AWS EKS). Security & Vulnerability Management: In-depth knowledge of security tools and practices (vulnerability management, pen testing, SCA, DAST, SAST), with hands-on experience using tools like Sysdig, Synk, and Blackduck. Cloud Platforms & Tools: Strong experience with cloud platforms (AWS, GCP, Azure) and open-source tools like Artifactory, Jira, Jenkins, Grafana, Prometheus, Datadog, Thanos, etc. Configuration Management: Proficiency with Terraform, Git, and CI/CD platforms (e.g., CircleCI, GitHub, Spinnaker). Networking Security: Solid understanding of TCP/IP, DNS, HTTP, Firewalls, VPNs, and other networking security concepts. Preferred Skills: Availability & Reliability: Knowledge of SLO/SLA, availability, reliability, and performance concepts. Incident Management: Experience with on-call rotations and incident management. Database Experience: Familiarity with databases, particularly Couchbase. Security Certifications: Relevant certifications in security or cloud technologies are a plus. Couchbase reimagines database technology to deliver a fast, flexible, and affordable cloud database platform, empowering developers to build applications with exceptional customer experiences. Trusted by over 30% of the Fortune 100, Couchbase drives innovation and customer success through its Capella platform. Benefits at Couchbase: Generous Time Off Program: Flexibility to care for yourself and your family. Wellness Benefits: Access to world-class medical plans, dental, vision, life insurance, and employee assistance programs. Financial Planning: RSU equity program, ESPP, retirement planning, and business travel insurance. Career Growth: Focused on your career development and success. Fun Perks: Ergonomic and comfortable office setup, food & snacks for in-office employees, and more!
Risk Management & Compliance Analyst
Johnson & Johnson Services, Inc
Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Johnson & Johnson is recruiting for some great opportunities for its Global Services (GS) in Bangalore, India which is well equipped with the latest technology and modern infrastructure. This is your chance to work with the best talent in a workforce that reflects the diverse markets Johnson & Johnson serves around the world, and an inclusive culture that values different perspectives and life experiences. Reimagine the possibilities at Johnson and Johnson Global Finance! We live this motto every day by creating exciting business solutions for the world s largest and most broadly-based healthcare company. As a member of our Global Finance team, you will have exclusive access to a network of financial professionals located in over 60 countries. This new network will help you build on your current skills and explore opportunities to grow your career in J&J. At J&J Global Finance, we value ideas for innovation and improvement and are committed to diversity and inclusion. Together we will reinvent business processes to become more effective, more efficient, and improve customer experience. We are proud to be an equal opportunity employer. The Global Services Finance organization provides best-in-class, cost-effective financial services, and compliance support in a J&J way to our Operating Companies around the world. Risk Management & Compliance (RM&C) is one of such initiative under Global Services Finance. RM&C, ASPAC is seeking a Risk Management & Compliance Analyst who will have responsibility for fulfilment of the SOX and Compliance programs across J&J entities, training and advisory along with all Compliance related support to different sectors and performing walkthroughs, sampling, testing the effectiveness of control deployment, documentation of testing results, remediation support, monitoring, audit support, project support etc. Key Responsibilities 1. Be compliant with applicable laws and regulations, and follow guidelines in the J&J Credo 2. Maintain Operational Excellence Deep expertise and knowledge of the Worldwide Procedures and compliance requirements for respective areas. Identify compliance risks and recommend solutions to remediate / prevent breach. Ensure strong internal controls are in place and maintain compliant environment across the Organisation. Responsible for performing Compliance Health Checks and other internal reviews to test the effectiveness of the control placement. Support timely closing & execution of financial periods as per closing calendar and in accordance with SLA commitments, fully observing Compliance, Internal Audit & SOX requirements. Accountable for supporting completeness, accuracy and validity of the actuals reported within process/entity scope. Work closely with all business process and IT team members to communicate compliance requirements, documentation standards, sign-offs and review processes. Provide trainings to all business process owners for any change/update in financial procedures. Support projects, business partnering with collaborators, assisting business process owners with adoption of J&J policies & procedures. Support in standard Compliance document requirements: Risk Control Matrix, Hand-off s, SOPs and submission of required SOX templates (system inventory templates, SOX questionnaires etc.). Performs control walkthrough, operational testing and discusses the findings with the process owners. Conduct compliance due diligence for transitions in-scope. Testing of preventive & detective UA/SOD Controls (e.g. granting, facilitating appropriateness & semi-annual reviews) across all ERP systems. Support Sectors during Corporate Financial Audits. Supervise and drive the Corrective Action Plan (CAP) process, to ensure audit(internal & external) recommendations and key control gaps per SOX testing are implemented and other internal control gaps are closed timely and effectively. Be A Trusted Business Partner Implement global Strategy & Solutions in line with taxonomy. Support Process Subject Matter Experts (SME's) and Operational Key Contacts (OKC's) to ensure cross sector, cross region, and cross process alignment, ensuring good documentation is maintained and consistency of a global approach Create radical Innovation Generate ideas, fosters, and implements continuous improvement attitude, identifying and pursuing process efficiency opportunities. Manage operational improvements, generating ideas and implementing in line with global standards. Qualifications Qualifications Education A minimum of a Bachelor s level degree or equivalent is required, preferably in accounting, finance, or related business subject area. ACA, CPA and/or other financial certifications is highly preferred. Required At least 1 - 3 years of post qualification experience is required: Strong knowledge and understanding of accounting and financial processes (for Trading as well as Manufacturing business), shared services and related subject matter Understanding of internal controls, risk management, US GAAP accounting, financial systems, IT development and/or production support Clear understanding of SOX 404 requirements Understanding of audit procedures and auditing practices Experience in developing and managing audit programs desirable Experience in performing audits of financial processes and systems required, preferably in manufacturing/trading/service industry At least 1 year Management / Supervisory / team handling experience i...
Research Associate Cell & Gene Therapy - Manufacturing
Aurigene Discovery Technologies
Key Responsibilities: Primary Cells & Cell Lines: Work with primary cells and cell lines in the context of immunology and immuno-oncology, with experience in developing and validating cell and gene therapy products. Cell-Based Assay Development: Lead the development and execution of cell-based assays, including immunological and immuno-oncological assays, for assessing the efficacy and safety of therapeutic products. Molecular Biology Techniques: Apply molecular biology techniques such as PCR, qPCR, cloning, and real-time PCR to analyze cellular responses and validate product candidates. Flow Cytometry & Sorting: Utilize flow cytometry and sorting techniques for detailed cell characterization, analysis of immune responses, and product quality control. Cross-Functional Collaboration: Collaborate closely with internal teams across manufacturing, quality assurance, clinical development, and supply chain management to advance the cell therapy pipeline. External Collaboration: Engage and coordinate with external collaborators, including contract research organizations (CROs) and vendors, to ensure smooth development and execution of the cell therapy product lifecycle. Project Management: Exhibit strict adherence to project timelines, ensuring that all work is completed on time while maintaining the highest standards of accuracy, integrity, safety, and quality. SOP & Documentation: Prepare and review Standard Operating Procedures (SOPs), protocols, regulatory documents, and reports in alignment with program requirements and compliance guidelines. Sterile Practices & Compliance: Adhere to systems and processes related to sterile practices, safety protocols, work ethics, and environmental health and safety standards. Key Skills: Cell-Based Assays: Expertise in the development and execution of cell-based assays, especially in immunology and immuno-oncology contexts. Ability to assess immune responses and therapeutic efficacy. Immuno-Oncology Knowledge: Deep understanding of immuno-oncology, including cellular and molecular mechanisms of cancer immunity, and how to translate this knowledge into therapeutic strategies. Molecular Biology Techniques: Proficiency in molecular techniques like PCR, qPCR, cloning, and real-time PCR for gene expression analysis, assay development, and validation. Flow Cytometry & Sorting: Expertise in flow cytometry, sorting, and analysis of cellular subsets, with an understanding of how these techniques can be applied to immuno-oncology. Stable Cell Line Generation: Experience in generating and maintaining stable cell lines for therapeutic and assay development purposes. Cross-Functional Team Collaboration: Proven ability to effectively work and communicate within a highly matrixed team environment, working across various functional areas to achieve product development goals. Vendor Management: Strong experience in managing external vendors, including CROs and service providers, ensuring timely and quality execution of outsourced activities. Competencies: Immunological and Immuno-Oncological Expertise: In-depth knowledge of immunology and immuno-oncology, with practical application to cell therapy development. Molecular Biology: Expertise in PCR, qPCR, cloning, and other molecular techniques used for gene analysis and validation of cell therapy products. Effective Communication: Strong verbal and written communication skills, with the ability to present complex data clearly and interact effectively with both internal and external stakeholders. Collaboration & Teamwork: Excellent interpersonal skills, able to collaborate effectively within teams and across functions to drive the progress of the cell therapy pipeline. Project Management: Ability to adhere to timelines and manage multiple projects effectively, ensuring that deadlines are met while maintaining quality and compliance. Vendor & Stakeholder Management: Competency in managing relationships with external partners, ensuring that project goals and deliverables are met to the required standard. Qualification : M.Sc. / MTech in Biotechnology with 3-7 years of experience in GMP Production
Assistant Manager Scientific Application Lead Dpex
Aurigene Discovery Technologies
Key Responsibilities: Project Management & Execution: Lead and manage application projects related to Electronic Lab Notebooks (ELN) and data analytics. Prepare and track project plans, allocate work, track progress, and ensure end-to-end project delivery. Status & Performance Reporting: Regularly report project status, quality assurance activities, and performance to the customer. Present status reports and ensure the team is aligned with project goals. Documentation & Process Control: Maintain project documentation, including defect prevention checklists and project metrics. Collate status reports and other key documents for project tracking and stakeholder communication. Design & Architecture Reviews: Participate in design and architecture reviews, providing valuable inputs and suggestions. Identify any issues and drive them to resolution to ensure project continuity. Scope & Specification Management: Strategize and draft scoping documents and specifications to clearly communicate the project roadmap and ensure alignment with customer and stakeholder expectations. Cross-Functional Coordination: Collaborate with different teams within the life sciences group to ensure that project requirements are well-captured and reflected in project plans. Plan budgets and resources accordingly. Data Analytics & Dashboard Development: Develop and manage operational, scientific, and trending dashboards, ensuring data accuracy and actionable insights for the business and scientific teams. Validation & Qualification: Lead computer system validation (CSV) executions and the qualification of servers to ensure compliance with necessary standards and regulations. Key Skills: Electronic Lab Notebook (ELN): Expertise in ELN systems and their implementation, including data management, documentation, and integration into lab processes. Project Management: Proficiency in project management tools and methodologies to ensure smooth project execution, including planning, tracking, and resource allocation. Data Analytics & Dashboarding: Strong skills in creating and managing dashboards that provide operational, scientific, and trending data insights for decision-making. Computer System Validation (CSV): Experience in performing system validation activities, ensuring compliance with regulatory standards and guidelines. Documentation & Reporting: Ability to maintain accurate documentation, such as defect prevention checklists, metrics, and status reports. Skilled in presenting information clearly to stakeholders. Cross-Team Collaboration: Strong ability to coordinate with different teams, capture requirements, and plan resources and budgets for each build order, ensuring smooth execution. Quality Assurance: Ensuring that quality assurance activities are in place throughout the project lifecycle, maintaining high standards of work and compliance. Competencies: Business Acumen: Understanding of the business impact of project outcomes and making decisions that align with business goals and customer needs. Presentation & Communication Skills: Strong verbal and written communication skills, with the ability to present complex project details and data insights to stakeholders. Interpersonal Skills: Ability to build strong working relationships with cross-functional teams and stakeholders, ensuring effective collaboration and issue resolution. Team Management: Experience managing project teams, guiding them through day-to-day activities, and providing product perspective and solutions. Negotiation Skills: Ability to negotiate timelines, budgets, and resources with stakeholders and vendors to achieve the best outcomes for the project. Stakeholder Management: Skilled in managing expectations and requirements of internal and external stakeholders, ensuring alignment and satisfaction. Qualification : Bachelors / Masters (Electronic and Instrumentation / Computer Science / IT /Chemistry) with 8 - 10 years of experience.
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