Regulatory Documentation Jobs in Bengaluru
765 Jobs Found
Senior Regulatory Affairs Specialist
Alivecor India
Senior Regulatory Affairs Specialist Location: Bangalore Company: AliveCor About AliveCor & The Opportunity AliveCor is a pioneer in **over-the-counter medical ECG devices**, dedicated to making heart health accessible. The company s **FDA-cleared medical-grade hardware and software** have enabled millions of heart health measurements, making a life-saving impact. We are seeking a **Senior Regulatory Affairs Specialist** to join our growing team. This is a critical role focused on **shaping regulatory strategy** for innovative mobile health technologies, managing product submissions, and ensuring compliance with international regulatory standards, including **ISO 13485 and FDA** Quality Systems. Role & Responsibilities As a Senior Regulatory Affairs Specialist, you will: Collaborate & Execute Regulatory Strategies: Work with product teams to **develop and execute global regulatory strategies** for registrations in the US, Europe, and other key regions. Manage Regulatory Submissions: Participate in the preparation and review of **global regulatory submissions**, including **510(k), de novo**, and other medical device filings. Support Government Interactions: Serve as the point of contact for regulatory agencies such as the **FDA, EU MDR**, and other international authorities, ensuring timely product approvals and licenses. Global Market Registrations: Drive product **registrations and renewals** for worldwide markets, supporting distributors with compliance documentation. Review & Approve Technical Documents: Assist in reviewing advertising, promotional materials, and technical documentation to ensure **compliance with applicable regulations**. ISO 13485 & FDA Compliance: Help implement and maintain an **ISO 13485 and FDA-compliant Quality Management System (QMS)**. Product Development Support: Collaborate with cross-functional teams (Engineering, Product, Quality) to support regulatory requirements during product development and design changes. Post-Market Compliance: Assist in post-market regulatory actions, including compliance with **reporting requirements and audits**. Requirements & Qualifications Experience & Education Experience: **4+ years in Regulatory Affairs within the medical device industry.** Education: Bachelor s degree in Science, Engineering, Math, or a medical field, or equivalent experience. Regulatory Experience with AI/ML: Experience in regulatory affairs for **software devices with AI/machine learning algorithms (SaMD)**. Core Regulatory Knowledge Global Regulatory Knowledge: Experience with **EU Medical Device Regulations (MDR)** and familiarity with regulatory processes in the US, EU, and Asia-Pacific regions. Regulatory Submissions: Experience preparing **510(k) submissions, pre-submissions, or de novo submissions** for medical devices. Skills Project Management: Ability to manage small projects with a focus on being organized, independent, and results-oriented. Analytical & Communication Skills: Excellent analytical, communication, and team collaboration skills, with a keen **attention to detail**. Preferred Qualifications Advanced Degree: Master s degree or regulatory affairs certifications such as **RAPS** (Regulatory Affairs Professionals Society). International Submissions: Experience in international submissions, especially in Asia-Pacific or LATAM regions. Perks & Benefits Working Model: Hybrid Working Model (Flexibility to work both remotely and in the office). Family Leave: Comprehensive Family Leave policies. Medical Benefits: Above-market family floater medical insurance, including coverage for parents/in-law parents. Office Perks: Complimentary lunch provided at the office and convenient metro connectivity. Qualification : Bachelors degree in Science, Engineering, Math, or a medical field, or equivalent experience
Lead/associate Manager - Case Processing1
Clinchoice
Lead/Associate Manager Case Processing 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a dynamic and experienced Lead/Associate Manager Case Processing to join our Pharmacovigilance team in Bengaluru. This role requires deep domain knowledge, leadership capability, and hands-on experience in handling Individual Case Safety Reports (ICSRs) across various sources. The ideal candidate will be responsible for managing day-to-day operations, ensuring compliance with global regulatory requirements, and mentoring a team of case processors. Key Responsibilities Operational Oversight Oversee and ensure the timely processing of ICSRs in accordance with SLA/KPI metrics. Allocate tasks effectively across the team to meet project deliverables and workload requirements. Proactively monitor team performance and work closely with team members to resolve operational or domain-related challenges. Risk & Issue Management Identify, escalate, and mitigate risks related to deliverables, compliance, or resourcing. Serve as a point of contact for internal stakeholders and clients regarding operational queries or escalations. Team Leadership & Performance Management Conduct regular performance evaluations, provide constructive feedback, and support career development of team members. Guide and mentor the team and Subject Matter Experts (SMEs) in ICSR processes, compliance standards, and MedDRA coding. Support functional capability development within the team and leadership pipeline. Training & Quality Assurance Conduct process and project-specific training as needed to ensure team competence and readiness. Ensure adherence to quality standards by contributing to quality system documentation, SOPs, and procedural updates. Provide feedback and suggestions to strengthen client/internal workflows and ensure continuous improvement. Process Improvement & Strategic Contribution Suggest and implement process enhancements to improve efficiency, accuracy, and compliance. Contribute to the development of scalable and sustainable pharmacovigilance processes. Collaborate cross-functionally to support strategic goals and business growth initiatives. Required Experience & Knowledge In-depth understanding of ICH-GCP, GVP modules, 21 CFR, and relevant global regulatory requirements. Proven expertise in managing high-volume ICSR workloads, including serious, non-serious, and potentially serious reports. Experience processing ICSRs from diverse sources: spontaneous, literature, solicited, regulatory authorities, and clinical trials. Exposure to therapeutic areas such as rare diseases and oncology is highly desirable. Experience in literature screening and review would be an added advantage. Proficient in MS Office applications (Excel, Word, Outlook, PowerPoint). Candidate Profile Education: Master s degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements. Experience: 10 12 years of relevant experience in pharmacovigilance, case processing, or related functions. Strong leadership skills with a proven ability to train, mentor, and manage cross-functional teams. Demonstrated ability to allocate resources, manage competing priorities, and maintain high-quality standards. Proactive, process-driven mindset with a commitment to continuous improvement and regulatory compliance. Work with a global leader in drug safety and pharmacovigilance services. Lead high-performing teams and contribute to the delivery of impactful healthcare solutions. Be part of a collaborative environment that values innovation, learning, and operational excellence. Apply now to lead meaningful work that impacts patient safety around the world. Qualification : Masters degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements
Associate - Packaging
Clinchoice
Associate Packaging Location: Bengaluru Employment Type: Full-Time Job Summary We are seeking a diligent Regulatory Compliance Team Lead to manage the qualification and compliance of packaging materials used in consumer products across the EMEA region. This role will focus on ensuring adherence to key EU and French regulations, coordinating testing and documentation, and collaborating closely with cross-functional teams to advance packaging compliance initiatives. Key Responsibilities Lead the qualification process for packaging materials used in consumer products, ensuring regulatory compliance across the EMEA region. Ensure packaging materials comply with relevant regulations including, but not limited to: EC 1223/2009 (Cosmetic Products Regulation) REACH Regulation (EC) No 1272/2008 French AGEC Law & Decree (including Article L. 5232) EU 2019/1021 (Persistent Organic Pollutants Regulation) EC 10/2011 (Food Contact Materials, if applicable) EU 528/2012 (Biocidal Products Regulation) Compliance with PFAS-related restrictions Conduct or oversee evaluations including: Packaging safety assessments (chemical compatibility, leaching/migration analysis) Stability and microbial integrity checks related to packaging Substance screening for SVHCs, POPs, phthalates, PFAS, and other restricted substances Review, validate, and manage supplier documentation such as Safety Data Sheets (SDS), Certificates of Compliance (CoC), Declarations of Conformity (DoC), migration test reports, and recyclability data. Collaborate effectively with cross-functional teams and external vendors/suppliers to ensure timely document collation and verification. Guide, mentor, and support junior team members involved in packaging compliance activities. Qualifications Bachelor s degree in Chemistry, Packaging Engineering, or a related field. Minimum of 2 3 years of experience in the life sciences industry, preferably within a packaging department. Strong understanding of packaging development and raw material chemistry. Excellent communication skills, demonstrating effective, timely, and proactive engagement with internal teams and external suppliers. Critical thinking ability to ask relevant questions, avoid redundant steps, and leverage past learnings to improve processes. Be part of a team driving compliance and innovation in consumer product packaging across the EMEA region. Collaborate with diverse experts and suppliers to ensure the highest standards of safety and regulatory adherence. Grow your career in a dynamic and evolving life sciences environment. Interested? Apply now to contribute your expertise to packaging compliance excellence! Qualification : Bachelors degree in Chemistry, Packaging Engineering, or a related field
Project Manager
Hm Constructions
Project Manager Location: Bengaluru Qualification: B.Tech (Civil preferred) Experience: 8+ years Job Description We are looking for an experienced and result-oriented Project Manager to lead and oversee end-to-end project execution, primarily in the infrastructure or construction sector. The ideal candidate will have a strong technical background, proven leadership skills, and the ability to manage timelines, budgets, and cross-functional teams effectively. Key Responsibilities Lead planning, execution, and delivery of construction/infrastructure projects within time and budget constraints. Coordinate with internal teams, consultants, contractors, and vendors to ensure smooth execution. Monitor project progress and proactively identify risks and delays, implementing corrective measures. Manage budgeting, cost control, resource planning, and reporting. Ensure adherence to safety, quality, and regulatory standards across the project lifecycle. Maintain clear documentation and communicate project status to stakeholders regularly. Lead project review meetings and ensure alignment across all departments. Required Skills & Experience B.Tech in Civil Engineering (preferred). Minimum of 8 years of experience in project management, preferably in infrastructure, highways, or construction domains. Proven ability to manage large-scale projects with multiple stakeholders. Strong leadership, decision-making, and organizational skills. Proficiency in project management tools (MS Project, Primavera, etc.). Excellent communication and client management skills. Qualification : B.Tech (Civil preferred)
Manager - Custody
Coindcx
Manager Custody Experience: 3 7 years Location: Bengaluru Team: Operations & Risk About CoinDCX At CoinDCX, we believe Change Starts Together. Our mission is to make Web3 and digital assets more accessible, secure, and user-friendly for everyone. In just six years, we've grown from India s first crypto unicorn to a leading platform with over 125 million users. As we continue to scale our impact, we re building the next generation of secure, scalable, and compliant Web3 infrastructure and we want you to be part of it. About the Role As Manager Custody, you will be responsible for overseeing digital asset custody operations, ensuring optimal deployment on Earn products, maintaining comprehensive risk monitoring, and aligning with regulatory compliance standards. This role is critical to safeguarding assets, improving operational efficiency, and scaling our Earn offerings in a rapidly evolving regulatory and technical landscape. Key Responsibilities 1. Token Deployment & Custody Operations Ensure 100% deployment of tokens across the Earn platform. Develop and execute token allocation strategies for staking, liquidity pools, and other avenues. Liaise with trading and portfolio management teams to identify deployment opportunities. Maintain accurate custody records and ensure timely, reliable disbursals. Create investment memos (IMs) for Earn deployments and work with the risk committee for approvals. Establish and maintain SOPs for custody and Earn operations. 2. Risk Monitoring & Incident Management Design and maintain a comprehensive risk monitoring framework with full coverage. Monitor for operational, technical, and counterparty risks in real-time. Conduct risk assessments for new deployments and token integrations. Manage incident response and ensure resolution of custody-related risk events within 24 hours. Deliver periodic risk reports to internal stakeholders and leadership. 3. Operational Excellence & Compliance Manage day-to-day custody operations in line with regulatory and internal policies. Interface with external custodians, service providers, and compliance bodies. Implement continuous improvement initiatives to drive process efficiency and accuracy. Ensure full documentation and audit readiness for all custody activities. 4. Cross-functional Collaboration Partner with Technology, Product, Compliance, and Risk teams to drive system improvements. Contribute to enhancements of Earn products from an operational and security standpoint. Support regulatory and audit processes through timely reporting and coordination. Performance Metrics 100% Token Deployment on Earn products 100% Risk Monitoring coverage Deployment Efficiency Ratio (actual vs. target) Risk Event Resolution Time (
Customer Support Engineer (cse)
Altem Technologies
Customer Support Engineer (CSE) Department: Technical Location: Bangalore Job Description The Customer Support Engineer (CSE) will be responsible for the maintenance, troubleshooting, and repair of Stratasys 3D printing equipment to ensure high customer satisfaction. This role involves direct interaction with customers, managing service calls, and maintaining equipment to the highest standards while following established procedures. Key Responsibilities Perform basic troubleshooting, installation, maintenance, and repair of Stratasys 3D printing equipment. Complete scheduled Preventative Maintenance and implement field modifications as required. Escalate unresolved technical issues to OEM teams following standard procedures. Maintain accurate and timely service logs, customer records, and internal documentation. Communicate regularly with customers to provide updates, resolve issues, and ensure proper follow-up. Ensure all tools and test equipment are properly maintained and calibrated. Adhere to Health and Safety regulations and other applicable regulatory requirements. Identify and support sales opportunities including new contracts, renewals, and system sales. Manage multiple open service issues efficiently, prioritizing tasks effectively. Requirements Educational Qualification: BE/B.Tech in Electrical Engineering or Mechanical Engineering. Diploma with 3+ years of experience servicing and operating 3D printing machines. Experience: Minimum of 3 years in a customer support or technical service role, preferably with experience in 3D printing equipment. Skills: Strong technical troubleshooting and problem-solving skills. Excellent communication and customer service abilities. Ability to manage multiple tasks and prioritize effectively. Qualification : BE/B.Tech in Electrical Engineering or Mechanical Engineering
Spare Parts Executive
Phillips Machine Tools
Position: Spare Parts Executive Location: Bangalore Employment Type: Full Time Experience Required: 5 8 Years Industry: Manufacturing / Engineering / Supply Chain Job Overview We are seeking a proactive and detail-oriented Spare Parts Executive to manage end-to-end operations for spare parts quotations, procurement, import coordination, and order fulfillment. The ideal candidate should have a solid background in parts handling, vendor coordination, import documentation, and customer communication. You will be a key link between suppliers, service teams, and customers, ensuring that spare parts are delivered efficiently and in compliance with timelines and regulatory standards. Key Responsibilities Handle incoming RFQs from customers and service engineers; provide accurate and timely quotations for spare parts. Process customer orders with a strong focus on precision, delivery timelines, and specifications. Coordinate with suppliers to: Check pricing and stock availability Negotiate payment and delivery terms Place purchase orders as needed Manage all import-related activities: Prepare and review import documentation Ensure compliance with import regulations, duties, and tariffs Coordinate with customs brokers to resolve clearance issues Monitor inventory and reorder levels to proactively meet customer demand and avoid stockouts. Maintain accurate records of RFQs, orders, supplier interactions, and stock transactions. Verify supplier invoices against ordered and received goods; resolve quantity or quality discrepancies swiftly. Communicate order status, delays, or changes clearly and proactively to customers and service teams. Continuously identify and implement improvements to streamline procurement and fulfillment workflows. Required Skills & Qualifications 5 8 years of experience in spare parts management, procurement, supply chain, or order coordination preferably in manufacturing or engineering services. Strong working knowledge of import/export regulations, documentation, and customs clearance. Experience in supplier negotiations and handling vendor communications. Proficiency in Microsoft Excel, ERP systems, and basic inventory management tools. Excellent communication and coordination skills. High attention to detail and ability to multitask in a deadline-driven environment. Strong problem-solving and decision-making capabilities. Competitive salary and performance incentives Health insurance and other employee benefits Dynamic and collaborative work environment Growth opportunities within operations and supply chain management Apply now to join a team committed to operational excellence and customer satisfaction.
Mechanical Design Engineer
Larsen & Toubro (l&t)
Job Title: Mechanical Design Engineer Location: Bengaluru Experience Required: 2 to 4 years Minimum Qualification: Bachelor of Engineering (BE) Key Skills Mechanical Product Design 3D Modeling (NX or SolidWorks) Engineering Drawing & Documentation Prototyping & Testing FEA & Tolerance Stack-Up Analysis DFMEA & Risk Assessment Cross-functional Collaboration Supplier & Manufacturing Support Job Summary We are looking for a talented and detail-oriented Mechanical Design Engineer to support the development of innovative mechanical products from concept through to production. The ideal candidate will have 2 4 years of hands-on experience in mechanical design, a strong grasp of engineering principles, and a passion for problem-solving and continuous improvement. Key Responsibilities Support mechanical design efforts for new product development from concept to launch. Create detailed 3D models, engineering drawings, and Bills of Materials (BOMs) using NX or SolidWorks. Build and test prototypes to validate design concepts and performance. Collaborate closely with electrical, software, industrial design, and manufacturing teams. Evaluate material choices, manufacturing processes, and cost implications during the design phase. Perform tolerance stack-up analyses, finite element analysis (FEA), and other engineering calculations. Participate in and support design reviews, DFMEA sessions, and risk assessments. Liaise with suppliers and contract manufacturers to ensure design integrity through production. Maintain accurate documentation in line with engineering change control and regulatory requirements. Contribute to continuous improvement initiatives and intellectual property (IP) development. Qualification : Bachelor of Engineering (BE)
Technical File Reviewer
Sgs India Private Limited
Job Title: Personal Protective Equipment (PPE) Products Technical File Reviewer Location: Bangalore Employment Type: Full-time Company Overview: SGS is the world s leading testing, inspection, and certification company. Recognized as the global benchmark for sustainability, quality, and integrity, we operate a network of 97,000 employees across 2,650 offices and laboratories worldwide. Our mission is to enable a better, safer, and more interconnected world by delivering expert solutions that make businesses more efficient and compliant. Position Summary: We are seeking a Technical File Reviewer for PPE products to join our team in Bangalore. The role involves reviewing technical documentation for various PPE categories in line with European legislation and CE marking requirements. The ideal candidate will have a strong technical background in PPE manufacturing, auditing, testing, or inspection, and be familiar with relevant performance standards. Key Responsibilities: Conduct thorough reviews of client technical files across various PPE product lines such as gloves, protective clothing, footwear, and respiratory masks Ensure documentation aligns with applicable performance standards and European regulatory requirements, including CE marking Coordinate effectively with SGS UK and affiliated notified bodies to manage certification processes Draft certificates upon successful review and support timely delivery Respond to client inquiries and provide clear, accurate updates on certification status Maintain high standards of accuracy, organization, and documentation quality Collaborate with internal and external stakeholders to resolve issues smoothly and efficiently Key Skills and Competencies: Strong understanding of PPE products and associated technical standards Familiarity with European PPE legislation, CE marking requirements, and certification processes High attention to detail with an analytical mindset Excellent written and verbal communication skills in English Proficiency in Microsoft Office and general computer literacy Ability to plan, prioritize, and manage multiple technical reviews under deadlines Professional, cooperative, and customer-focused demeanor Qualifications: A technical qualification in a relevant field (engineering, textiles, materials science, etc.) is preferred Work experience in PPE product manufacturing, auditing, inspection, or testing is essential Prior exposure to reviewing certification files and working with notified bodies is highly desirable
Quality Assessors
5c Network Pvt. Ltd.
Position: Quality Assessors (Radiology) Location: Bangalore, Karnataka, India Type: Full-Time Experience Required: 2 8 years Qualifications: B.Sc. in Radiology or Imaging Technology Job Summary: We are seeking dedicated and detail-oriented Quality Assessors / Radiographers to join our dynamic team. This is a unique opportunity to be part of a rapidly evolving healthcare ecosystem, working alongside leading radiologists and AI experts to transform diagnostic care through technology. Recent graduates or professionals with a B.Sc. in Radiology or Imaging Technology Candidates passionate about quality in healthcare and looking to grow within a technology-driven environment Key Responsibilities: Perform quality assessments of medical imaging studies to ensure accuracy and diagnostic value Collaborate with radiologists and AI engineers to support model validation and improvement Maintain documentation and compliance with clinical and regulatory standards Provide feedback on imaging quality and assist in continuous improvement initiatives What We Offer: Competitive Salary: Attractive compensation with additional benefits Professional Development: Ongoing training, mentorship, and skill-building opportunities Innovative Work Environment: Access to cutting-edge imaging and AI tools in a state-of-the-art facility Career Growth: Clear advancement pathways in a fast-growing healthcare AI organization Pioneers in AI Healthcare: Work at the forefront of artificial intelligence in radiology Commitment to Quality & Care: Make a meaningful impact on patient outcomes Tech-Enabled Innovation: Hands-on experience with the latest technologies and medical imaging systems Qualification : B.Sc. in Radiology or Imaging Technology
Assistant Manager - Corporate Finance & Treasury
Zetwerk Manufacturing Businesses Pvt. Ltd.
Job Title: Assistant Manager Corporate Finance & Treasury Location: Bangalore Department: Corporate Finance Role Overview We are seeking a detail-oriented and proactive Assistant Manager Corporate Finance & Treasury to manage and optimize Zetwerk s treasury operations. This role involves overseeing cash management, regulatory compliance, banking relationships, and treasury accounting to ensure smooth financial operations and robust control across the organization. Key Responsibilities Monitor and manage daily cash positions across multiple banks and entities to optimize fund utilization, including intercompany fund flows, interest calculations, and short-term investments. Oversee internal and external data management processes to ensure accuracy and compliance; prepare and deliver timely financial and regulatory reports to stakeholders and authorities. Ensure strict adherence to regulatory requirements and contractual covenants, preparing necessary documentation and proactively managing any compliance risks. Execute various payments (vendor, statutory, FX, interest, etc.) in coordination with Accounts Payable and other internal teams, while maintaining compliance with internal controls and Standard Operating Procedures (SOPs). Build and maintain strong relationships with banks and financial institutions to support financing needs, forex transactions, trade finance, and daily banking operations including documentation and account management. Manage end-to-end processes related to issuance and amendments of Letters of Credit (LC) and Bank Guarantees (BG). Monitor foreign exchange exposures and coordinate timely booking of forwards and other hedging instruments to mitigate currency risks. Prepare comprehensive treasury MIS reports on a monthly, quarterly, and annual basis, including cash flow statements, debt schedules, utilization reports, and FX exposure analysis. Support the management of working capital loans (Cash Credit, WCDL, Overdraft) and term loans to optimize financing costs. Ensure accuracy of treasury-related accounting entries and reconciliations in close coordination with the finance and accounts teams. Qualifications & Experience Qualified Chartered Accountant (CA) or MBA with 2 to 6 years of experience in treasury operations, working capital management, and trade finance instruments. Proficient in handling LC/BG issuance, banking documentation, and online banking portals. Solid experience in treasury accounting, cash flow forecasting, and management information system (MIS) preparation. Strong ethical standards, integrity, and problem-solving skills. Ability to thrive in fast-paced, dynamic environments while consistently delivering high-quality results. Join Zetwerk and be part of a fast-growing organization where your expertise in treasury and corporate finance will directly impact the company s financial health and growth trajectory.
Manager - Ehs (environment, Health, And Safety)
Pharmed Limited
Manager - EHS (Environment, Health, and Safety) Location: Bangalore Experience: 7-10 years of experience, preferably in the Pharma Industry Industry: Pharmaceutical Education Qualification: Bachelor s/Master s Degree in Engineering, Health, Industrial Management, Science, Environmental Science, or related field. Certifications Required: OSHA, EHS, CPR, CSP, ASP, CIH, HAZWOPER. Fire Department Certification may be preferred. Role Overview We are looking for a skilled and experienced Manager - EHS to join our pharmaceutical company in Bangalore. The role requires a strong understanding of safety and environmental regulations and a proactive approach to managing health, safety, and environmental risks in the workplace. The Manager - EHS will oversee the development, implementation, and management of EHS programs, ensuring compliance with local, state, and central regulations and company policies. Key Responsibilities EHS Program Development & Implementation: Develop and implement safety and environmental programs that create and maintain a safe work environment for employees. Safety Inspections & Audits: Conduct regular safety inspections and audits to ensure compliance with EHS regulations. Investigate accidents/incidents and develop corrective actions to prevent future occurrences. Risk Assessments: Perform risk assessments for new processes, equipment, and materials. Implement measures to mitigate identified risks and ensure the safety of all employees. Employee Safety Training: Conduct regular training for employees on safety procedures, emergency response, and EHS best practices. Regulatory Compliance: Oversee activities related to permits, environmental regulations, and compliance with safety standards. Ensure documentation is up-to-date and regulatory filings are completed accurately. Documentation & Reporting: Maintain and update safety data sheets, compliance records, and incident reports. Prepare and present EHS performance reports to management and stakeholders. Incident & Emergency Response Management: Ensure the development and maintenance of emergency response plans. Conduct regular emergency drills and training sessions to ensure readiness. Vendor & Contractor Compliance: Ensure that vendors and contractors adhere to EHS standards and company policies. Health & Wellness Programs: Develop and implement health and wellness initiatives that promote physical and mental well-being for employees. Continuous Improvement: Monitor compliance with safety standards and enforce safety regulations. Promote initiatives for continuous improvement in safety practices and performance. Insurance & Claims Management: Coordinate with insurance providers for claims management and risk assessments related to employee safety and workplace hazards. Skills & Qualifications EHS Knowledge: In-depth knowledge of EHS regulations and best practices as mandated by local, state, and central regulatory bodies. Analytical & Problem-solving Skills: Strong ability to analyze data, identify issues, and develop solutions to improve safety and environmental practices. Communication Skills: Excellent written and verbal communication skills to effectively report, train, and communicate with employees and management. Software Proficiency: Proficient in Microsoft Office and EHS management software to track, report, and monitor EHS metrics and documentation. Team Player & Independent Worker: Ability to work independently and as part of a team to achieve EHS objectives. Industry Knowledge: Experience evaluating work procedures and processes to align with industry standards and best practices. Travel Requirements: Willingness and ability to travel extensively for inspections, audits, and compliance checks. This is a fantastic opportunity to work with a leading pharmaceutical company where you will have the chance to make a significant impact on employee safety and environmental compliance. You will work in a dynamic, fast-paced environment, focusing on developing and implementing strategies that drive safety, health, and environmental initiatives across the organization. Qualification : Bachelors/Masters Degree in Engineering, Health, Industrial Management, Science, Environmental Science, or related field.
Investigator Payments Analyst
Iqvia
Investigator Payments Analyst Location: Bengaluru Job Overview: The Investigator Payments Analyst is responsible for supporting the delivery of all required start-up contracting activities for selected sponsors, studies, or multi-protocol programs. This includes pre-award activities and providing essential operational and financial contracting support. The role ensures compliance with sponsor requirements, regulatory guidelines, and project timelines. Essential Functions: Grant Estimates & Proposal Support: Develop simple investigator grant estimates and proposal text to support the proposal development process. Contracting Tools & Systems: Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, ensuring alignment with the Scope of Work and Project Plan. Collaboration & Communication: Coordinate with sponsors, stakeholders, and RSU regions to ensure successful delivery of projects in compliance with sponsor requirements and the RSU Management Plan. Operational & Financial Support: Provide operational and financial contracting support to facilitate business development and efficient initiation and maintenance of clinical trials, ensuring compliance with regulatory requirements. Documentation Support: Assist in creating and reviewing scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance. Contracting Intelligence: Contribute to the collection, interpretation, analysis, and dissemination of contracting intelligence for assigned studies and the company. Efficiency & Reporting: Ensure contracting efficiency and adherence to project timelines and financial goals, and report on performance metrics and out-of-scope activities. Compliance & Quality Standards: Ensure compliance with contract management and quality standards, providing administrative and operational support to investigators and managers as required. System & Database Management: Accurately complete and maintain internal systems (including CTMS), databases, tracking tools, timelines, and project plans. Qualifications: Education: Bachelor's degree required. Experience: At least 1 year of relevant experience, including demonstrable experience as a contract negotiator or equivalent combination of education, training, and experience. Skills & Knowledge: Negotiation & Communication: Strong negotiation and communication skills to facilitate contract discussions and maintain professional relationships with sponsors. Interpersonal Skills: Ability to work effectively in teams and with internal and external stakeholders. Technical Writing: Strong technical writing skills for creating and reviewing proposals and documentation. Clinical Trial Knowledge: Understanding of clinical trial environments and the drug development process. Regulatory Knowledge: Knowledge of GCP/ICH guidelines, applicable regulatory requirements, and SOPs. Organizational Skills: Excellent organizational and planning skills for managing contracting activities. Software Proficiency: Strong knowledge of Microsoft Office and other relevant software tools. Contract Management: Good understanding of clinical trial contract management, including pricing models, proposals, and budgets. Additional Skills: Ability to interpret pricing models, prepare proposals, bid grids, and budgets. Ability to work in a matrix team environment and build effective working relationships with sponsors, co-workers, and managers. Ability to exercise independent judgment when negotiating contracts and making decisions. This role offers an exciting opportunity for individuals who have a strong foundation in contract negotiation and management, along with an understanding of the clinical trial landscape. If you are a detail-oriented, proactive individual with a passion for working in the healthcare and clinical trial industries, we encourage you to apply. Qualification : Bachelor's degree required.
Cybersecurity Leader - India Hub
Schneider Electric
Cybersecurity Portfolio Manager Location: Bengaluru, India About Schneider Electric Schneider Electric is a global leader in energy management and automation, driving digital transformation for efficiency and sustainability. With a presence in over 100 countries and revenues of ~ 25 billion (FY2016), our 144,000+ employees help customers optimize their energy and processes in safe, reliable, efficient, and sustainable ways. From simple switches to advanced automation systems, our technologies reshape industries, transform cities, and enrich lives. At Schneider Electric, we believe that Life Is On. Cybersecurity at Schneider Electric Cybersecurity is a core pillar of Schneider Electric s digital strategy, ensuring secure IT/OT convergence and enabling our partners and customers to thrive in today s digital economy. Our cybersecurity efforts focus on: Strong digital governance and risk management Robust risk prevention, detection, and response strategies Protection of high-value assets Comprehensive security metrics and compliance About the Role We are seeking an experienced Cybersecurity Portfolio Manager to lead our product security initiatives within the Energy Management (EM) Central CTO Office. This role is crucial in driving transversal security strategies, aligning regulatory, technical, and business teams, and ensuring our products meet the highest security and data protection standards. You will report to the VP of Cybersecurity Innovation and Architecture and collaborate closely with product security architects, security advisors, and key stakeholders across the organization. Key Responsibilities Product Security Management: Oversee security aspects of product development and implementation, ensuring compliance with industry standards and regulations. Governance, Risk, and Compliance (GRC): Ensure adherence to security frameworks, policies, and compliance requirements. Project Management: Lead security initiatives, managing resources, timelines, and budgets effectively. Stakeholder Collaboration: Act as a bridge between technical teams, regulatory bodies, and business units to align security objectives. Documentation & Reporting: Maintain security process documentation, dashboards, and reports to track security performance and compliance. Qualifications Required: Bachelor s degree in Computer Science, Information Security, or a related field. 4 6 years of experience in cybersecurity, with a focus on product security. Strong knowledge of security principles (IT and OT), GRC, and data protection. Experience in project management and leading cross-functional teams. Excellent communication skills, with the ability to simplify complex security concepts for non-technical stakeholders. Structured, detail-oriented, and highly organized. Ability to advocate for security best practices across the organization. Familiarity with security frameworks and standards (e.g., ISO/IEC 27001, NIST). Certifications such as CISSP, CISM, or CISA (preferred). Leadership & Soft Skills Strong presentation and cross-functional collaboration skills. Ability to organize and facilitate meetings and workshops. Adaptability to shifting priorities, deadlines, and challenges. Experience working in global, matrixed organizations. Problem-solving mindset with a proactive approach to risk identification and mitigation. Self-motivated with the ability to work independently and handle multiple tasks under pressure. Join us in shaping a secure digital future at Schneider Electric! Qualification : Bachelors degree in computer science, Information Security, or a related field.
Enterprise Risk Management (ERM) Manager
Capgemini Invent
Job Title: Enterprise Risk Management (ERM) Manager Location: Bengaluru Job Description: We are seeking an experienced and dynamic Enterprise Risk Management (ERM) Manager to join our team in Bengaluru. In this role, you will be responsible for overseeing and assessing the organization s overall risk profile, identifying potential risks, and implementing strategies to mitigate them. You will work closely with cross-functional teams to integrate risk management into business strategies, policies, and operational processes, ensuring the organization s resilience and success. Key Responsibilities: Develop, implement, and maintain comprehensive risk management frameworks, policies, and processes across the organization. Conduct thorough risk assessments to identify, evaluate, and prioritize risks related to operations, finance, compliance, and strategic objectives. Design, implement, and monitor enterprise-wide risk mitigation strategies to address identified risks. Collaborate with senior leadership to ensure alignment between risk management initiatives and broader business objectives. Prepare and present detailed reports on key risk indicators (KRIs) to senior management and board members. Lead the enterprise risk management cycle, encompassing risk identification, assessment, mitigation, monitoring, and reporting. Develop risk management models and scenario analyses to predict potential impacts on business operations and long-term goals. Work closely with internal audit, legal, compliance, and finance teams to ensure that identified risks are appropriately managed and mitigated. Design and lead company-wide risk training and awareness programs to ensure that all employees understand and contribute to effective risk management practices. Monitor industry trends, emerging regulations, and best practices to proactively manage and mitigate new risks. Oversee the implementation and management of risk-related technology tools or software to enhance risk identification, tracking, and mitigation efforts. Maintain effective communication and collaboration with external auditors, insurers, legal advisors, and other external stakeholders on risk-related matters. Primary Skills: Risk Identification & Assessment Risk Mitigation & Control Strategic Thinking Analytical & Problem-Solving Project Management Attention to Detail Cross-functional Collaboration Knowledge of Regulatory & Compliance Standards Reporting & Documentation Qualifications: Bachelor's degree in Business, Finance, Risk Management, or a related field. Proven experience in enterprise risk management or a related field. Strong knowledge of risk management methodologies, tools, and frameworks. Excellent communication and presentation skills, with the ability to articulate complex risk concepts to senior leadership. Proficiency in risk management software and technology tools. What We Offer: A collaborative and inclusive work environment where innovation and strategic thinking are valued. Opportunities for career advancement and professional development in risk management. Competitive salary and benefits package. Qualification : Bachelor's degree in Business, Finance, Risk Management, or a related field.
Finance Manager
Devrev
Overview: We are seeking an experienced Accounting Manager to oversee and manage all aspects of the accounting function, ensuring the accuracy, compliance, and efficiency of financial reporting and processes. You will play a pivotal role in maintaining financial integrity, supporting audits, and driving continuous improvements in accounting operations. As a key member of the finance team, you will collaborate with cross-functional teams to ensure alignment with corporate objectives and regulatory requirements. Key Responsibilities: Closing and Reviewing Books of Accounts: Oversee and manage the month-end and year-end financial close processes, ensuring accuracy and completeness of financial data. Review and reconcile general ledger accounts, sub-ledgers, and supporting documentation to ensure financial integrity. Prepare journal entries, adjustments, and ensure proper documentation and approvals for all financial transactions. Ensure compliance with accounting standards (GAAP/IFRS) and internal financial policies and procedures. Month-End Financial Reporting: Prepare and deliver accurate, timely month-end, quarter-end, and year-end financial reports to senior management. Analyze financial performance, identify variances, and provide actionable insights to improve financial performance. Ensure that all financial data is reported in compliance with corporate standards and reporting timelines. Assist in the preparation of management reports, KPI dashboards, and executive summaries for leadership. Audit Management: Lead and manage internal and external audits, acting as the key point of contact for auditors and facilitating a smooth audit process. Prepare audit schedules, reconciliations, and promptly respond to audit queries. Implement corrective actions based on audit recommendations and ensure continuous readiness for future audits. Maintain proper documentation and internal controls to support audit compliance. Compliance & Regulatory Adherence: Ensure adherence to local, regional, and international accounting regulations, including tax laws, statutory reporting, and corporate governance standards. Stay informed of regulatory changes and implement necessary updates to financial processes to remain compliant. Coordinate with external regulatory bodies and tax authorities as required to ensure compliance. Accounting Operations: Oversee day-to-day accounting functions, including accounts payable, accounts receivable, payroll, and expense management. Manage the handling of fixed assets, intercompany transactions, and financial consolidations. Ensure accurate and up-to-date financial records and documentation for all transactions. Process Improvement & Automation: Identify opportunities to streamline and improve accounting processes to enhance efficiency and reduce errors. Lead or contribute to finance-related projects aimed at enhancing financial systems and tools. Support the automation of manual accounting processes to improve data accuracy and operational efficiency. Cross-Functional Collaboration: Work closely with cross-functional teams to ensure alignment on financial processes and reporting. Support global finance initiatives by collaborating with international teams to standardize processes and reporting requirements. Financial Controls & Risk Management: Establish and maintain effective internal controls to safeguard the integrity of financial reporting. Identify potential financial risks and implement mitigation strategies to protect the company s financial assets. Assist in the development and implementation of risk management policies to ensure compliance and safeguard against financial risks. Qualifications: Strong knowledge of accounting standards (GAAP/IFRS), financial reporting, and compliance requirements. Proven experience in managing internal and external audits and ensuring adherence to regulatory compliance. Advanced proficiency in Microsoft Excel and other financial reporting tools. Strong analytical skills, attention to detail, and a proactive, solution-oriented approach to problem-solving. Culture: At DevRev, our culture is built upon the values of hunger, humility, honesty, and acting with heart. We are committed to helping build the world s most customer-centric companies, leveraging design, data engineering, and machine intelligence to empower engineers in better serving their customers.
Embedded Engineer
Solaredge Technologies
About the Role: As a Senior Embedded Engineer at SolarEdge India R&D, you will be a key player in developing embedded systems and firmware for our advanced solar energy products. You will be responsible for designing, implementing, and testing embedded software, ensuring its reliability, performance, and seamless integration with our hardware platforms. What You Will Be Doing: Lead the design and development of embedded systems and firmware for SolarEdge's solar power products, including inverters, power optimizers, energy storage solutions, and communication interfaces. Collaborate with cross-functional teams (hardware engineers, software developers, and product managers) to define system requirements and architect innovative embedded solutions. Develop and implement efficient and reliable embedded software in C/C++ for various microcontrollers and processors used in SolarEdge products. Conduct thorough testing and verification of embedded software to ensure its functionality, performance, and compliance with quality standards. Troubleshoot and debug embedded software and hardware interactions, identifying and resolving issues throughout the product development lifecycle. Participate in code reviews, providing constructive feedback to team members and ensuring code quality and adherence to coding standards. Stay abreast of industry trends and advancements in embedded systems to propose and integrate cutting-edge technologies into SolarEdge's products. Collaborate with manufacturing and validation teams to support the production and testing of embedded systems. Support the certification process by providing necessary documentation and technical inputs to comply with relevant safety and regulatory standards. Design and implement control algorithms for digital control of power electronics systems, such as DC/DC converters and DC/AC inverters operating at high switching frequencies. Develop device drivers and execute tight interrupt loops in bare metal implementations. Optimize firmware algorithms to enhance system efficiency and reliability. Job Requirements: Bachelor's (B.E./B.Tech.) or Master's (M.E./M.Tech.) degree in Electrical/Electronics Engineering, Computer Science, or a related field. 4+ years of experience in embedded systems design and firmware development. Proficiency in C and C++ programming, with hands-on experience in RTOS and bare-metal development. Strong understanding of microcontrollers, microprocessors, and embedded system architectures. Hands-on experience with ARM-based processors (e.g., TI DSP Controllers, ST, Renesas). Good knowledge of RTOS concepts. Ability to identify and troubleshoot hardware and software technical problems. Working knowledge of protocols and device drivers for SPI, I2C, UART, and CAN. Strong knowledge and proven experience in developing control algorithms for power electronics converters/inverters. Experience developing device drivers and executing tight interrupt loops in bare metal. Experience optimizing firmware algorithms for system efficiency and reliability. Working knowledge of JTAG/SWD debuggers. Experience in board bring-up, peripheral integration, and device driver development. Strong debugging and problem-solving skills. Knowledge of software development tools, version control systems, and debugging tools. Excellent communication and teamwork skills. Experience in the renewable energy or power electronics industry is a plus. Results-oriented mindset. Qualification : Bachelor's (B.E./B.Tech.) or masters degree (M.E./M.Tech.) in Electrical/Electronics Engineering, Computer Science, or a related field.
Senior Embedded Engineer
Solaredge Technologies
About the Role: As a Senior Embedded Firmware Engineer at SolarEdge India R&D, you will be a key player in developing embedded systems and firmware for our advanced solar energy products. You will be responsible for designing, implementing, and testing embedded software, ensuring its reliability, performance, and seamless integration with our hardware platforms. Responsibilities: Lead the design and development of embedded systems and firmware for SolarEdge's solar power products, including inverters, power optimizers, energy storage solutions, and communication interfaces. Collaborate with cross-functional teams (hardware engineers, software developers, and product managers) to define system requirements and architect innovative embedded solutions. Develop and implement efficient and reliable embedded software in C/C++ for various microcontrollers and processors used in SolarEdge products. Conduct thorough testing and verification of embedded software to ensure its functionality, performance, and compliance with quality standards. Troubleshoot and debug embedded software and hardware interactions, identifying and resolving issues throughout the product development lifecycle. Participate in code reviews, providing constructive feedback to team members and ensuring code quality and adherence to coding standards. Stay abreast of industry trends and advancements in embedded systems to propose and integrate cutting-edge technologies into SolarEdge's products. Collaborate with manufacturing and validation teams to support the production and testing of embedded systems. Support the certification process by providing necessary documentation and technical inputs to comply with relevant safety and regulatory standards. Key Responsibilities (Continued): Design and implement control algorithms for digital control of power electronics systems, such as DC/DC converters and DC/AC inverters operating at high switching frequencies. Develop device drivers and execute tight interrupt loops in bare metal implementations. Optimize firmware algorithms to enhance system efficiency and reliability. Job Requirements: Bachelor's (B.E./B.Tech.) or Master's (M.E./M.Tech.) degree in Electrical/Electronics Engineering, Computer Science, or a related field. 10+ years of experience in embedded systems design and firmware development. Proficiency in C and C++ programming, with hands-on experience in RTOS and bare-metal development. Strong understanding of microcontrollers, microprocessors, and embedded system architectures. Hands-on experience with microprocessors such as TI DSP Controllers, ST, and Renesas. Experience with advanced SW control methods such as SIL/HIL. Experience with test automation. Experience with PLECS/Typhoon HIL is desirable. Good knowledge of RTOS concepts. Ability to identify and troubleshoot hardware and software technical problems. Working knowledge of protocols and device drivers for SPI, I2C, UART, and CAN. Strong knowledge and proven experience in developing control algorithms for power electronics converters/inverters. Experience developing device drivers and executing tight interrupt loops in bare metal. Experience optimizing firmware algorithms for system efficiency and reliability. Working knowledge of JTAG/SWD debuggers. Experience in board bring-up, peripheral integration, and device driver development. Strong debugging and problem-solving skills. Knowledge of software development tools, version control systems, and debugging tools. Excellent communication and teamwork skills. Experience in the renewable energy or power electronics industry is a plus. Results-oriented mindset. About SolarEdge: SolarEdge recognizes its talented and diverse workforce as a key competitive advantage. Our business success is a reflection of the quality and skill of our people. SolarEdge is committed to seeking out and retaining the finest human talent to ensure top business growth and performance. Qualification : Bachelor's (B.E./B.Tech.) or masters degree (M.E./M.Tech.) in Electrical/Electronics Engineering, Computer Science, or a related field.
Dm/manager Car T Engineering
Aurigene Discovery Technologies
Key Responsibilities: QMS Documentation & Activities: Expertise in preparing and managing QMS (Quality Management System) documentation related to facility and engineering activities, including writing SOPs for lab instruments, equipment, and utilities, as well as preparing qualification documents (DQ, IQ, OQ, PQ), deviation handling, change control, risk assessment, CAPA, and commissioning documents. Cross-functional Collaboration: Work closely with both internal teams and external stakeholders to ensure the smooth implementation and execution of engineering maintenance activities. This includes document preparation, process review, implementation, and follow-ups with various functional teams and vendors. Facility Modification & Commissioning: Manage facility modification projects, including overseeing commissioning and qualifications documentation to ensure that changes are aligned with regulatory and operational standards. Lab Equipment Operations & Maintenance: Oversee the operation and maintenance of lab equipment, including CO2 incubators, deep freezers, autoclaves, biosafety cabinets, LAF, stability chambers, cooling incubators, lab centrifuges, water baths, hot air ovens, incubator shakers, water purification systems, bioreactors, cold rooms, and liquid nitrogen systems. Analytical Instrument Operations & Maintenance: Manage the operation and maintenance of analytical instruments such as flow cytometers, spectrophotometers, multimode microplate readers, chemical image systems, gel image systems, osmometers, pH & conductivity meters, weighing balances, and western blot instruments. Utility Equipment Maintenance: Manage the operation and maintenance of HVAC systems (including air handling units, chillers, cooling towers, and BMS monitoring systems), utility equipment such as transformers, DG sets, air compressors, nitrogen generators, and LT panels. Preventive Maintenance Planning: Prepare and review schedules for periodic maintenance of lab instruments, utility equipment, and facility infrastructure. Ensure that all maintenance activities are conducted timely and in accordance with operational needs. Corrective and Preventive Actions: Coordinate and oversee corrective and preventive actions related to observations during internal and external audits, ensuring continuous compliance with quality standards. Vendor and OEM Coordination: Serve as the primary point of contact for external vendors and OEM service providers for periodic preventive maintenance (PM), calibration activities, and addressing breakdown issues. Project & Facility Modification Support: Coordinate and support the execution, verification, and successful completion of new projects or facility modification activities. Safety and Sustainability: Ensure compliance with safety practices and procedures, sustainability programs, and hygiene maintenance standards across the facility. Key Skills: QMS Documentation: In-depth experience in writing and managing SOPs and qualification documents (DQ, IQ, OQ, PQ) for lab instruments and utility systems. Proficient in handling deviations, change controls, risk assessments, CAPA, and commissioning documentation. Lab Equipment Expertise: Strong knowledge in the operation and maintenance of various lab equipment, including incubators, freezers, autoclaves, biosafety cabinets, stability chambers, centrifuges, and water purification systems. Analytical Instruments Management: Expertise in handling and maintaining analytical instruments like flow cytometers, spectrophotometers, microplate readers, and various other lab-based instruments used for experiments and analysis. Utility Systems & HVAC Management: Strong knowledge of utility equipment management, including HVAC systems, transformers, DG sets, air compressors, and nitrogen generators. Preventive & Corrective Maintenance: Ability to plan, schedule, and execute preventive and corrective maintenance tasks for lab instruments and utility systems, ensuring minimal downtime. Vendor Management: Expertise in coordinating with external vendors and OEMs for service contracts, maintenance, calibration, and addressing equipment failures or breakdowns. Project Coordination: Ability to manage and execute facility modification projects, ensuring timely delivery and alignment with operational needs. Safety & Compliance: Sound knowledge of safety practices, hygiene, sustainability programs, and regulatory compliance within facility and equipment operations. Competencies: Attention to Detail: High level of attention to detail in handling documentation, operational processes, and safety practices. Problem Solving: Strong analytical skills to troubleshoot and resolve issues in equipment, systems, and processes. Interpersonal & Communication Skills: Excellent communication and interpersonal skills to effectively collaborate with internal teams, external vendors, and service providers. Project Management: Ability to manage projects efficiently, ensuring all modifications, installations, and maintenance activities are completed on time and within scope. Team Collaboration: Team-oriented mindset with a collaborative approach to work alongside internal departments and external contractors/service providers. Adaptability: Ability to adapt to changing priorities, work in dynamic environments, and manage multiple tasks simultaneously. Qualification : Diploma/BE in electrical and electronics, with QMS related certifications with 10+Years of experience.
Scientist / Sr. Scientist Cell & Gene Therapy Manufacturing
Aurigene Discovery Technologies
Key Responsibilities: Cell Therapy Product Development: Lead the development of new cell therapy products, overseeing the validation process to ensure successful transition to the next stage of product development. Cell Culture Techniques: Apply extensive experience in different types of cell culture techniques, ensuring the optimal growth and maintenance of cells required for therapy products. Large-Scale Bioreactor Operations: Oversee the operation of large-scale bioreactors for biologicals, catering to both commercial and clinical requirements. Ensure that all aseptic operations are performed to the highest standards. Gene Transfer Methods: Utilize and manage both viral and non-viral methods of gene transfer, incorporating these techniques into cell therapy protocols. Equipment and Facility Maintenance: Maintain equipment and facilities in compliance with industry standards, ensuring the implementation of effective calibration, preventive maintenance, and validation programs. Documentation & Reporting: Prepare and review cGMP-compliant documentation, including SOPs, batch records, checklists, protocols, and reports. Ensure that all documentation is accurate and up to date for regulatory purposes. Team Leadership & Collaboration: Lead a team, providing critical technical and scientific recommendations, troubleshooting, and fostering innovation. Manage the day-to-day activities of team members while encouraging excellence in all aspects of work. Cross-Functional Collaboration: Work closely with cross-functional teams to advance the company s cell therapy pipeline, collaborating effectively in a matrixed team environment. Production Planning: Organize workflow by assigning responsibilities and preparing work schedules to ensure that production targets are met efficiently. Adherence to Project Timelines: Exhibit strict adherence to project timelines, ensuring that quality, safety, integrity, and accuracy are maintained throughout the development and production process. Sterile Practices & Compliance: Understand and enforce systems and processes related to sterile practices, safety protocols, work ethics, and environmental health standards. Key Skills: Cell Therapy Development: In-depth experience in the development of cell therapy products, with the ability to manage the entire development lifecycle from early-stage research through to product validation. Cell Culture Expertise: Expertise in cell culture techniques, both in small and large-scale systems, ensuring cell integrity and performance for clinical and commercial applications. Bioreactor & Aseptic Operations: Proficiency in large-scale bioreactor operations and aseptic techniques, ensuring contamination-free environments for cell and tissue production. Gene Transfer Methods: Hands-on experience in viral and non-viral gene transfer methods, including plasmid DNA transfections and viral vector-based techniques, critical for gene therapy applications. cGMP Documentation: Familiarity with preparing and reviewing cGMP documents, such as SOPs, protocols, and batch records, ensuring compliance with regulatory requirements. Team Management: Leadership skills to manage, guide, and motivate a team, ensuring high levels of collaboration, productivity, and excellence. Problem-Solving & Troubleshooting: Excellent troubleshooting skills, with the ability to innovate and provide technical solutions in the face of operational challenges. Cross-Functional Collaboration: Ability to collaborate across various teams and functions, working towards shared goals and the successful advancement of the cell therapy pipeline. Project & Time Management: Ability to manage multiple projects simultaneously, ensuring that work is completed on time while maintaining high quality and safety standards. Competencies: Leadership & Team Development: Strong leadership skills, with the ability to direct and motivate a team, fostering an environment of growth, innovation, and high performance. Communication Skills: Excellent verbal, written, and presentation skills, with experience in writing grants and research articles. Ability to effectively communicate with internal teams, external collaborators, and stakeholders. Attention to Detail: High attention to detail, ensuring accuracy and precision in all aspects of product development, documentation, and operational procedures. Problem-Solving & Innovation: Ability to troubleshoot and solve complex scientific problems, utilizing innovative approaches to overcome technical and operational challenges. Adaptability & Efficiency: Demonstrated ability to adapt to changing priorities and work in fast-paced, high-pressure environments while maintaining efficiency and meeting production targets. Quality & Safety Focus: Strong focus on maintaining high standards of safety, quality, and compliance throughout all phases of cell therapy development and production. Qualification : M.Sc. / MTech in Life Sciences with 12-18 years of experience in GMP Productioninvolving intense Cell Culture
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