Inspection Readiness Jobs in Hyderabad

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms Qualification : Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Join Amgen s Mission of Serving Patients At Amgen, you ll be part of something bigger driven by our shared mission to serve patients with serious illnesses. Since 1980, we ve been pioneering biotech innovations, focusing on oncology, inflammation, general medicine, and rare disease.Join us to help make a lasting impact on patients lives while transforming your career. Case Management QA Vendor Associate What You Will Do: As a Case Management QA Vendor Associate, you will play a vital role in ensuring the quality and compliance of global case intake and processing activities. You will oversee vendors, manage case quality, and ensure adherence to regulatory requirements while supporting inspections, audits, and continuous improvement initiatives. Key Responsibilities: Monitor and ensure vendors deliver high-quality Individual Case Safety Reports (ICSRs) that meet global regulatory standards. Act as the US/EU local safety office and primary FDA/EMA point of contact for safety reporting. Provide training and resources to vendors to maintain compliance and quality. Perform quality control reviews, trend analysis, and generate reports on case quality. Manage vendor case processing timelines for adverse event intake, triage, and submission. Support inspections, audits, and CAPA (Corrective and Preventive Action) activities. Assist in Periodic Aggregate Safety Reports (PASR) processes and maintain a state of inspection readiness. Collaborate with local safety offices and attend vendor management meetings. Analyze QC trends and recommend improvements. Support onboarding and offboarding of vendor staff. What We Expect of You Basic Qualifications: Bachelor s degree with 3 years of related experience, or Associate s degree with 5 years of related experience, or High school diploma/GED with 7 years of related experience Previous experience in managing teams, projects, or resource allocation Preferred Skills: Knowledge of global pharmacovigilance regulatory requirements Proficiency in safety case processing and experience with global safety databases Strong communication skills, attention to detail, and experience supporting audits/inspections Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook What You Can Expect from Us Amgen is committed to supporting your professional growth and well-being with a collaborative, science-driven culture and a competitive Total Rewards Plan aligned with industry standards. Equal Opportunity Amgen is an Equal Opportunity Employer and embraces diversity. We provide reasonable accommodations for individuals with disabilities throughout the application process.

Company: Evergent About Evergent: Evergent is a leading technology provider that works behind the scenes to impact the lives of millions of consumers across the world, every single day. Having onboarded over 800 million subscribers for our clients, Evergent is trusted by the likes of SonyLIV, HBO, the NBA, AT&T and BBC to power the subscriber journeys and experience for their subscribers across more than 180 countries. This has been made possible due to our secret sauce - our people. With an approach of bringing together the best of Silicon Valley and the best of India, our team of 500+ Evergenters have delivered world-class technology products and have driven industry-leading transformation projects for our clients. Our solutions help our clients innovate with new revenue streams, increase subscriber loyalty, and control churn - without requiring an overhaul of their legacy billing and payment systems. Our true multi-tenant SaaS approach means that our clients can go live in weeks, and not months or years. At the same time, our carrier-grade infrastructure assures our clients of an unparalleled ability to scale across the globe. As we continue on our journey of creating a positive impact for businesses and consumers - we would love for you to come and meet with us. Job Title: Facilities Admin Executive Experience: 3+ Years Location: Hyderabad Job Summary: The Facilities Admin Executive will oversee and manage the day-to-day operations of office facilities, ensuring a safe, clean, and efficient work environment. This role requires strong organizational skills, attention to detail, and the ability to manage multiple tasks simultaneously. The ideal candidate will have experience in facility management, vendor coordination, and administrative support. Key Responsibilities: Vendor Management: Oversee the maintenance, repair, and upkeep of the office premises, including HVAC, plumbing, electrical, Fire Alarm System and general office maintenance. Maintaining the inventory for housekeeping material, office supplies, stationery, etc. Manage the reception area, including visitors, customers and partners entry formalities and necessary arrangements. Monitoring the daily checklists and activity execution. Required Skills and Qualifications: Bachelor s degree or relative field. 3+ years of experience in facilities management, office administration, or a related role. Strong organizational and multitasking abilities. Good communication and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Work Environment: Office-based role with movement between Evergent office locations as needed. May require flexibility to handle emergencies outside of regular business hours / days. May require flexibility to travel within the city for office related assignments. Qualification : Bachelors degree or relative field.

Job Title: Data Governance Lead Job Location: Hyderabad Job Description As a Data Governance Lead at Kanerika, you will be responsible for defining, leading, and operationalizing the data governance framework, ensuring enterprise-wide alignment and regulatory compliance. Key Responsibilities: Governance Strategy & Stakeholder Alignment Develop and maintain enterprise data governance strategies, policies, and standards. Align governance with business goals: compliance, analytics, and decision-making. Collaborate across business, IT, legal, and compliance teams for role alignment. Drive governance training, awareness, and change management programs. Microsoft Purview Administration & Implementation Manage Microsoft Purview accounts, collections, and RBAC aligned to org structure. Optimize Purview setup for large-scale environments (50TB+). Integrate with Azure Data Lake, Synapse, SQL DB, Power BI, Snowflake. Schedule scans, set classification jobs, and maintain collection hierarchies. Metadata & Lineage Management Design metadata repositories and maintain business glossaries and data dictionaries. Implement ingestion workflows via ADF, REST APIs, PowerShell, Azure Functions. Ensure lineage mapping (ADF Synapse Power BI) and impact analysis. Data Classification & Security Governance Define classification rules and sensitivity labels (PII, PCI, PHI). Integrate with MIP, DLP, Insider Risk Management, and Compliance Manager. Enforce records management, lifecycle policies, and information barriers. Data Quality & Policy Management Define KPIs and dashboards to monitor data quality across domains. Collaborate on rule design, remediation workflows, and exception handling. Ensure policy compliance (GDPR, HIPAA, CCPA, etc.) and risk management. Business Glossary & Stewardship Maintain business glossary with domain owners and stewards in Purview. Enforce approval workflows, standard naming, and steward responsibilities. Conduct metadata audits for glossary and asset documentation quality. Automation & Integration Automate governance processes using PowerShell, Azure Functions, Logic Apps. Create pipelines for ingestion, lineage, glossary updates, tagging. Integrate with Power BI, Azure Monitor, Synapse Link, Collibra, BigID, etc. Monitoring, Auditing & Compliance Set up dashboards for audit logs, compliance reporting, metadata coverage. Oversee data lifecycle management across its phases. Support internal and external audit readiness with proper documentation. Requirements 7+ years of experience in data governance and data management. Proficient in Microsoft Purview and Informatica data governance tools. Strong in metadata management, lineage mapping, classification, and security. Experience with ADF, REST APIs, Talend, dbt, and automation via Azure tools. Knowledge of GDPR, CCPA, HIPAA, SOX and related compliance needs. Skilled in bridging technical governance with business and compliance goals. Benefits Employee Benefits Culture: Open Door Policy: Encourages open communication and accessibility to management. Open Office Floor Plan: Fosters a collaborative and interactive work environment. Flexible Working Hours: Allows employees to have flexibility in their work schedules. Employee Referral Bonus: Rewards employees for referring qualified candidates. Appraisal Process Twice a Year: Provides regular performance evaluations and feedback. Inclusivity and Diversity: Hiring practices that promote diversity: Ensures a diverse and inclusive workforce. Mandatory POSH training: Promotes a safe and respectful work environment. Health Insurance and Wellness Benefits: GMC and Term Insurance: Offers medical coverage and financial protection. Health Insurance: Provides coverage for medical expenses. Disability Insurance: Offers financial support in case of disability. Child Care & Parental Leave Benefits: Company-sponsored family events: Creates opportunities for employees and their families to bond. Generous Parental Leave: Allows parents to take time off after the birth or adoption of a child. Family Medical Leave: Offers leave for employees to take care of family members' medical needs. Perks and Time-Off Benefits: Company-sponsored outings: Organizes recreational activities for employees. Gratuity: Provides a monetary benefit as a token of appreciation. Provident Fund: Helps employees save for retirement. Generous PTO: Offers more than the industry standard for paid time off. Paid sick days: Allows employees to take paid time off when they are unwell. Paid holidays: Gives employees paid time off for designated holidays. Bereavement Leave: Provides time off for employees to grieve the loss of a loved one. Professional Development Benefits: L&D with FLEX- Enterprise Learning Repository: Provides access to a learning repository for professional development. Mentorship Program: Offers guidance and support from experienced professionals. Job Training: Provides training to enhance job-related skills. Professional Certification Reimbursements: Assists employees in obtaining professional certifications.

Job Title: Data Governance Architect Job Location: Hyderabad Job Description As a Data Governance Architect at Kanerika, you will play a pivotal role in shaping and executing the enterprise data governance strategy. Your responsibilities include: What You Will Do: Strategy, Framework, and Governance Operating Model Develop and maintain enterprise-wide data governance strategies, standards, and policies. Align governance practices with business goals like regulatory compliance and analytics readiness. Define roles and responsibilities within the governance operating model. Drive governance maturity assessments and lead change management initiatives. Stakeholder Alignment & Organizational Enablement Collaborate across IT, legal, business, and compliance teams to align governance priorities. Define stewardship models and create enablement, training, and communication programs. Conduct onboarding sessions and workshops to promote governance awareness. Architecture Design for Data Governance Platforms Design scalable and modular data governance architecture. Evaluate tools like Microsoft Purview, Collibra, Alation, BigID, Informatica. Ensure integration with metadata, privacy, quality, and policy systems. Microsoft Purview Solution Architecture Lead end-to-end implementation and management of Microsoft Purview. Configure RBAC, collections, metadata scanning, business glossary, and classification rules. Implement sensitivity labels, insider risk controls, retention, data map, and audit dashboards. Metadata, Lineage & Glossary Management Architect metadata repositories and ingestion workflows. Ensure end-to-end lineage (ADF Synapse Power BI). Define governance over business glossary and approval workflows. Data Classification, Access & Policy Management Define and enforce rules for data classification, access, retention, and sharing. Align with GDPR, HIPAA, CCPA, SOX regulations. Use Microsoft Purview and MIP for policy enforcement automation. Data Quality Governance Define KPIs, validation rules, and remediation workflows for enterprise data quality. Design scalable quality frameworks integrated into data pipelines. Compliance, Risk, and Audit Oversight Identify risks and define standards for compliance reporting and audits. Configure usage analytics, alerts, and dashboards for policy enforcement. Automation & Integration Automate governance processes using PowerShell, Azure Functions, Logic Apps, REST APIs. Integrate governance tools with Azure Monitor, Synapse Link, Power BI, and third-party platforms. Requirements 15+ years in data governance and management. Expertise in Microsoft Purview, Informatica, and related platforms. Experience leading end-to-end governance initiatives. Strong understanding of metadata, lineage, policy management, and compliance regulations. Hands-on skills in Azure Data Factory, REST APIs, PowerShell, and governance architecture. Familiar with Agile methodologies and stakeholder communication. Benefits Employee Benefits Culture: Open Door Policy: Encourages open communication and accessibility to management. Open Office Floor Plan: Fosters a collaborative and interactive work environment. Flexible Working Hours: Allows employees to have flexibility in their work schedules. Employee Referral Bonus: Rewards employees for referring qualified candidates. Appraisal Process Twice a Year: Provides regular performance evaluations and feedback. Inclusivity and Diversity: Hiring practices that promote diversity: Ensures a diverse and inclusive workforce. Mandatory POSH training: Promotes a safe and respectful work environment. Health Insurance and Wellness Benefits: GMC and Term Insurance: Offers medical coverage and financial protection. Health Insurance: Provides coverage for medical expenses. Disability Insurance: Offers financial support in case of disability. Child Care & Parental Leave Benefits: Company-sponsored family events: Creates opportunities for employees and their families to bond. Generous Parental Leave: Allows parents to take time off after the birth or adoption of a child. Family Medical Leave: Offers leave for employees to take care of family members' medical needs. Perks and Time-Off Benefits: Company-sponsored outings: Organizes recreational activities for employees. Gratuity: Provides a monetary benefit as a token of appreciation. Provident Fund: Helps employees save for retirement. Generous PTO: Offers more than the industry standard for paid time off. Paid sick days: Allows employees to take paid time off when they are unwell. Paid holidays: Gives employees paid time off for designated holidays. Bereavement Leave: Provides time off for employees to grieve the loss of a loved one. Professional Development Benefits: L&D with FLEX- Enterprise Learning Repository: Provides access to a learning repository for professional development. Mentorship Program: Offers guidance and support from experienced professionals. Job Training: Provides training to enhance job-related skills. Professional Certification Reimbursements: Assists employees in obtaining professional certifications.

PHP Lead Experience: 7 to 15 Years Employment type: Permanent Job function: Information Technology Location: Hyderabad Job Description: Design and implement integrations between our games and various social networks using a combination of PHP and JavaScript SDKs. In-depth knowledge and experience of object-oriented analysis and design, with Java and Java EE technologies, using frameworks such as Laravel is essential along with Gateway. Familiarity with source control (Subversion, git), bug tracking systems (JIRA), build and dependency management systems (ant, ivy, maven), continuous integration, packaging and deployment. Experience in software development based on common agile application development methodologies, TDD/BDD/Scrum/Kanban. Develop large and complex modules and components of larger system designs. Design large and complex modules and components of larger system designs. Actively participate in quality assurance activities including design and code reviews, unit testing, defect fixes, operational readiness. Develop and conduct targeted technical mentoring, training and workshops. Understand, and be able to articulate, the distinction between game-specific features and game-agnostic features. Design and implement APIs and services that provide a strong and stable platform that can be leveraged by all our games. Employee Benefits: 5 day working Free Lunch and Snacks Festivals, family day and team outing Health insurance Flexi working environment Company Sponsored certifications Travel opportunities Bonuses- Fixed, variable, project linked, referral etc. Disclaimer: Machint is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Machint is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.machint.com and Follow us on Twitter, Facebook, LinkedIn, and YouTube.

Python Developer Experience: 5-10 Years Job type: New Employment type: Permanent Job function: Information Technology Preferred work mode: Work from office Location: Hyderabad Job description: Design and implement integrations between our games and various social networks using a combination of PHP and Javascript SDKs In depth knowledge and experience of object-oriented analysis and design, with - Java and Java EE technologies, using frameworks such as Spring/Jersey essential Familiarity with source control (Subversion, git), bug tracking systems (JIRA), build and dependency management systems (ant, ivy, maven), continuous integration, packaging and deployment. Experience in software development based on common agile application development methodologies, TDD/BDD/Scrum/Kanban Develop large and complex modules and components of larger system designs Design large and complex modules and components of larger system designs Actively participate in quality assurance activities including design and code reviews, unit testing, defect fixes, operational readiness Develop and conduct targeted technical mentoring, training and workshops Understand, and be able to articulate, the distinction between game-specific features and game-agnostic features Design and implement APIs and services that provide a strong and stable platform that can be leveraged by all our games

Summary Business Data Migration expert for Finance on LDC ERP program ensures data is delivered according to global/deployment/country requirements and timelines and responsible for data migration activities in a deployment (above-country) for Data objects in his/her scope. The data includes but is not limited to Finance master data, Assets, AP, AR, GL, P&L. Acts as the functional SPoC for data migration on the assigned objects for a given release. About the Role Key Responsibilities: • Perform or ensure data cleansing tasks are completed on time • Complete data collection for manual/construction objects on time • Work together with IT counterparts to prepare value mappings • Create and maintain master lists if applicable for assigned objects • Provide business insights and information to technical teams for extraction and conversion from the legacy system(s) for assigned data objects • Work together with IT team and country Business Data Owners to identify objects in scope for country • Ensure data readiness & verify quality throughout data journey for assigned data objects • Verify that data is fit for purpose (incl. alignment with internal/external stakeholders) • Approve upload files before and after load for all assigned data objects (including formal approval) • Perform manual (type-in) data loads into target clients where applicable for assigned objects • Perform dual maintenance • Execution and approval of data verification scripts • Act as SPoC for assigned objects as part of defect management process during Hypercare Essential Requirements: • Bachelor's or master's degree preferred • 5+ years in country & global roles (ERP project implementation experience preferred) • Strong knowledge about the Finance business processes especially in the area of Finance master data, Assets, GL and P&L reporting, WBS, Internal orders, AP, AR etc. Desirable Requirements • Data Migration experience preferred • Good communication and negotiation skills, good stakeholder management • Strategic and hands on way of working (running meetings, tracking progress, managing issues) • Strong Excel Skills Qualification : Bachelor's or master's degree preferred

About Our Team Our Security Architecture team, reporting to the CISO, plays a critical role in designing and implementing robust security solutions across all digital domains. The team works alongside Security Operations & SOC and Governance, Risk, and Compliance teams, ensuring the organization s technological infrastructure is secure and aligned with best industry practices. Under the leadership of the Security Architecture Lead, the team effectively supports our cybersecurity strategy, focusing on building a secure environment across all sectors. Role Overview The Health & Science Cybersecurity FTE will work under the direction of the Security Lead to ensure the cybersecurity resilience of our Health & Science sectors. This role will focus on implementing security measures and strategies tailored to the specific challenges of healthcare and scientific environments. Main Responsibilities Portfolio Optimisation & Functional Gaps Assess the efficacy of deployed security solutions within the health and science sectors and benchmark against leading vendor solutions. Evaluate the organization s cybersecurity solution portfolio and address identified gaps. Policies, Tech Standards & Security by Design Collaborate with IT, enterprise risk, and other teams to design and update policies and technical standards for hardware/software and applications in health and scientific settings. Work with product development teams to ensure cybersecurity practices are integrated and maintained throughout the product lifecycle in healthcare and scientific projects. Regularly review and update security policies to ensure the protection of health and scientific data throughout the acquisition and development lifecycle. Perform certification and accreditation processes for new systems in healthcare and scientific environments to ensure compliance and security readiness. About You Experience 5-7 years of professional experience (equivalent combination of experience and education is acceptable). Experience working in international environments. Proven expertise within cybersecurity teams, particularly in health and scientific environments. Track record of designing and implementing security solutions tailored to the unique challenges and regulatory requirements of health and science sectors. Soft Skills Experience working in large digital teams, understanding the connection between business and digital processes. Strong stakeholder management and communication skills, particularly with senior leadership. Problem-solving mindset and ability to take initiative. A hands-on, pragmatic attitude towards driving change. Positive, "can-do" attitude. Technical Skills Proficiency in the Microsoft tech stack and leveraging ecosystem synergies. Experience with AGILE or similar project management frameworks. Working knowledge of information security management frameworks (ISO/IEC 27001, ITIL, NIST, NISD, CISSP/CCSP, QxP, CIS20). Education Bachelor's and master's degree (preferred) in Information Technology, Computer Science, Cybersecurity, or Information Security. Languages Proficiency in English. Qualification : Bachelors and masters degree (preferred) in any of the following fields of study: Information Technology, Computer Science, Cybersecurity or Information Security

Job Description: Safety Officer Experience: 2+ Years Qualification: Diploma in Construction Safety, Diploma in Health & Safety Job Description: We are looking for a Safety Officer to ensure the safety and health of all personnel on site and in our workplace. The ideal candidate should have a minimum of 2 years of experience in safety management, specifically in construction or industrial environments, and be well-versed in safety standards and practices. Key Responsibilities: Toolbox Talks & Safety Training: Prepare and deliver Toolbox Talks to ensure the team is up-to-date on safety protocols. Organize and arrange safety training classes and workshops for employees, including first aid and fire safety training. Arrange monthly safety bulletin distributions to keep the team informed about the latest safety practices. Accident Reports & Statistics: Prepare monthly safety statistics to track accidents, incidents, and overall safety performance. Draft and maintain accident reports and analyze root causes to improve future safety measures. Safety Inspections & Equipment Checks: Conduct regular inspections of workplace safety equipment, such as fire extinguishers, and ensure they meet safety standards. Conduct routine safety inspections and ensure all safety regulations and compliance requirements are followed. Safety Competitions & Awareness Programs: Organize safety competitions such as quizzes, slogan competitions, and poster exhibitions to increase awareness and engagement among employees. Safety Documentation & Reporting: Maintain and update safety checklists to ensure compliance with all required safety procedures. Participate in management meetings to discuss safety performance, risks, and improvement strategies. Other Duties: Provide suggestions and improvements on health and safety measures in the workplace. Collaborate with various departments to ensure a safe working environment and compliance with health and safety regulations. Qualifications and Skills: Experience: Minimum 2 years of experience in safety management in construction or similar environments. Certifications: Diploma in Construction Safety and Diploma in Health & Safety are mandatory. Technical Skills: Ability to prepare and deliver toolbox talks and safety training programs. Skilled in preparing accident reports, safety statistics, and checklists. Strong knowledge of safety regulations and procedures in construction or industrial environments. Communication: Excellent communication and interpersonal skills to handle safety training, awareness programs, and safety meetings. Additional Skills: Ability to organize safety competitions, such as quizzes and poster competitions, to raise safety awareness among employees. Detail-oriented with strong organizational and planning skills to arrange and track safety activities and training. What We Offer: Competitive salary and benefits. A dynamic and collaborative work environment. Opportunities for professional development and growth in the field of safety management. Qualification : Diploma in Construction Safety and Diploma in Health & Safety are mandatory.

Position: Solution Consultant SAP EAM Location: Hyderabad, Telangana, India Employment Type: Full-Time, Salaried Compensation: Base Salary + Bonus + Benefits About Innovapptive: Innovapptive is transforming the industrial workforce by connecting front-line workers, back-office teams, and assets through the only patented, Code-Free connected worker platform for SAP and IBM Maximo. Our platform digitizes manual, paper-based processes in maintenance, operations, and supply chain with highly configurable mobile apps, giving real-time visibility and actionable insights to back-office teams. Trusted by global leaders like Newmont Mining, Shell, UNICEF, and Reckitt Benckiser, we save companies millions by improving asset uptime, productivity, safety, and workforce efficiency. Backed by Tiger Global Management and recently funded by Vista Equity Partners, Innovapptive is rapidly growing and committed to empowering 350 million industrial front-line workers worldwide. Role Overview: The Solution Consultant will engage directly with plant maintenance leaders to consult on value improvement, maturity assessments, process enhancements, and mobility best practices. You will lead solution design workshops, drive adoption of Innovapptive s cloud-based SaaS connected worker solutions, and support customers in achieving key operational KPIs such as: Efficient plant maintenance execution Timely maintenance work completion Compliance with regulatory and industry standards Key Responsibilities: Collaborate with customers and internal teams to gather and prioritize requirements, translating them into actionable product features. Lead solution design workshops and create value models demonstrating cost savings and operational improvements. Document test scenarios and maintain traceability matrices aligned with business requirements. Promote rapid, agile solution iterations ensuring quality, efficiency, and speed to value. Ensure delivery timelines and quality standards are met, driving ROI and user adoption post-implementation. Partner with product management to influence roadmap and feature prioritization. Analyze user personas to tailor solutions that alleviate core pain points of maintenance professionals. Develop training materials and documentation to empower end-users. Collaborate across engineering, design, marketing, and sales teams to ensure aligned product development. Embrace a startup mindset adaptable, resilient, and entrepreneurial. Qualifications & Experience: Bachelor s degree in Computer Science, IT, or related field. 5+ years as a solution engineer or functional expert in Smart Manufacturing / Connected Plant applications. 3+ years domain experience in Maintenance and Operations. Strong expertise in Plant Maintenance processes: Work Order Planning & Scheduling, Notifications, Execution, Functional Locations, Inspections, and Permits. Experience with full cycle project implementations is preferred. Excellent analytical, problem-solving, organizational, and communication skills. Self-motivated, able to work independently and within teams. Leadership experience and project coordination skills are a plus. Certifications like CCBA or CBAP are desirable. What We Offer: Collaborative, innovative, and entrepreneurial work environment Opportunities to work with global brands on impactful projects Competitive salary and benefits including medical insurance for family Paid maternity and paternity leave Generous vacation and paid time off Bi-annual performance reviews and transparent feedback culture Extensive learning and development resources Active interest groups and clubs (Book Reading, Toastmasters, Sports, Music) Innovapptive is an equal opportunity employer committed to diversity and inclusion. Qualified applicants will receive consideration without regard to protected characteristics under applicable law. Qualification : Bachelors degree in Computer Science, IT, or related field.

Senior Analyst Controllership, Finance Locations: Hyderabad & Bangalore Company: Arcesium Company Overview Arcesium is a global financial technology firm helping the world s most sophisticated financial institutions tackle complex, data-driven challenges. Our innovative platform, built to anticipate risks and power transformational business outcomes, continues to redefine operational excellence in the investment management industry. With a solid market foundation and strong growth trajectory, Arcesium offers an intellectually stimulating environment, where proactive ownership, collaboration, and continuous learning are core to our success. About the Role We are looking for a dynamic and detail-oriented Senior Analyst Controllership, Finance to join our growing Finance team in Hyderabad or Bangalore. This role is ideal for a qualified Chartered Accountant with strong technical acumen in accounting, taxation, regulatory compliance, and financial controls. You will be responsible for ensuring the integrity and accuracy of financial records, maintaining strong internal controls, managing key audits, and ensuring compliance with statutory and regulatory frameworks. Key Responsibilities Financial Accounting & Reporting Drive accuracy and completeness of financial statements and month-end close processes. Ensure compliance with applicable accounting standards, including Ind AS, and corporate governance requirements. Taxation & Compliance Direct Taxation: Manage TDS payments and returns, advance tax, annual income tax filings. Handle income tax assessments and departmental correspondence. Indirect Taxation: Oversee monthly GST filings and payments, annual GST returns, and GST refund applications. Respond to GST notices and regulatory queries. Other Statutory Requirements: Ensure timely filings with ROC, RBI, SEZ, STPI, and compliance with the Companies Act and corporate laws. Maintain accurate documentation for inspections and audits. Internal Controls & Process Improvement Collaborate with internal teams to assess and strengthen internal financial controls. Conduct regular process reviews and feedback sessions to implement improvements. Prepare and maintain SOPs, RCMs, and key dashboard metrics. Stakeholder & Audit Management Serve as the point of contact for all external advisors on tax and compliance matters. Coordinate and support: Statutory audits Internal audits Tax audits IFC audits Other external/regulatory audits Treasury & Payables Oversee accounts payable processes and ensure timely, error-free vendor payments. Manage treasury operations, including cash flow forecasting, banking, and forward contracts. What You ll Need Qualifications & Experience Chartered Accountant (CA) with 4 6 years of post-qualification experience. Strong technical knowledge of: Indian Accounting Standards (Ind AS) Companies Act Direct and Indirect Taxation Skills & Tools Strong analytical mindset and a problem-solving approach. Hands-on experience with Oracle ERP (preferred). Excellent communication and interpersonal skills. A proactive team player with high attention to detail. Be part of a high-performing team tackling some of the most complex financial challenges. Enjoy a culture that values intellectual curiosity, autonomy, and inclusive collaboration. Work with a firm that truly values professional development and diverse perspectives. Equal Opportunity Employer Arcesium is committed to creating an inclusive work environment. We do not discriminate on any basis and encourage candidates from all backgrounds to apply. Qualification : Chartered Accountant (CA) with 46 years of post-qualification experience.

Let s do this. Let s change the world. In this vital role you will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes in tools like Veeva Study Startup. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Defining the scope, objectives, and approach of the validation process, creating detailed validation plans, and aligning them with project timelines and resources Perform Validation testing, including Installation Qualification (IQ), Operational Qualification (OQ) for new and existing SSU Systems Ensure compliance with industry standards, regulations and internal policies during all validation activities. (GxP, FDA 21 CFR Part 11) Identify, document, and track defects during the testing process. Collaborate with development teams to define validation requirements, resolve defects and validate fixes. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the Veeva Vault Management (VVM) to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and stakeholders to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. Assist in the development and continuous improvement of validation processes and procedures Stay up to date with industry trends, best practices and evolving regulatory needs We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 10 to 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Experience in defining and executing validation strategies aligned with regulatory requirements Familiarity with risk-based approaches to validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Excellent documentation and report writing skills Good-to-Have Skills: Proficiency in automation tools, data systems, and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodology Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

Summary The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures. Sr. eCompliance Specialist provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations, etc.. Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and/or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects About the Role Key Responsibilities: • Quality oversight of Project and operational activities of GxP systems (e.g.: changes, Periodic Reviews, deviations, etc.) Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects. • Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. • Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. • Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support. • Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented. • Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions. • Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System. • Perform supplier qualification assessment activities • Provides audit support as assigned and in case of CAPAs, provides the required Quality support Essential Requirements: • GXP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements. • On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems. • Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date and can be presented during audits and inspections without delays and issues • Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported. • Client/stakeholder satisfaction and corresponding feedback Desirable Requirements: • 5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance • Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.) • Good experience in the development, implementation and lifecycle management of computerized systems in regulated environments • Experienced in the operational management of GxP solutions including its related technologies to support the operation • Experience in GxP supplier qualification activities • Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) • Experienced in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space • Successful cross-divisional/functional work with complex international teams • Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude • Ability to effectively interact and present to Management • Ability to influence without hierarchical authority and build trusted partnerships • Self-starter with experience in initiating and delivering projects and processes • Excellent communication, negotiation, facilitation, and interpersonal skills Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Key Accountabilities: Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent PAREXEL at sponsor marketing and technical meetings. Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Extensive knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness). Knowledge and Experience: Competent in written and oral English. Excellent communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.

Key Accountabilities: Project Management: Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Ability to manage competing priorities and flexibility to change. Attention to detail. Ability to successfully work as part of a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge and Experience: Competent in written and oral English. Good communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. Qualification : Educated to degree level in a relevant discipline and/or equivalent work experience.