43 21 Cfr Jobs - Page 2

What you will do In this vital role You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. Role Description: In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owners, business analysts, developers, test/validation engineers, project managers and scrum masters responsible for the ongoing design, development, management, and optimization of Amgens digital products enabling the regulatory submission content automation initiative. You will also be the reporting manager for this team and will be responsible for the coaching and development of these resources. The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires deep expertise in handling the end-to-end development and delivery of customer-facing digital product capabilities and platforms including generative AI, structured content management. They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team to ensure all collaborators feel informed and engaged Oversee the software development lifecycle, ensuring standard methodologies in development, testing, and deployment across the product teams Lead and handle large, teams with varied strengths within a matrixed organization, collaborating with geographically dispersed teams, including those in the US and international locations Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India Developing talent, motivating the team, delegating effectively, championing diversity within the team, and acting as a role model of servant leadership Ensuring global ways of working are embedded in the local organization Develop a culture of collaboration, innovation, and continuous improvement, driving talent development, motivation, and effective delegation Fostering standard methodology sharing and alignment with business goals Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet Participate in team member and leadership meetings, working with other parts of the organization and functional groups to ensure successful delivery and alignment with strategy, compliance, and regulatory requirements Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 10 - 12 years of experience in Engineering, IT or related field OR Bachelors degree with 12 - 14 years of experience in Engineering, IT or related field Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to oversee and guide a team to translate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products. Proven experience working with large-scale data environments comprising data pipelines, and enterprise cloud solutions. In-depth knowledge of data engineering concepts, ETL processes, and data architecture principles. Strong understanding of cloud computing principles, particularly within the AWS ecosystem Working knowledge of 21 CFR, ISO 13485 and experience working in regulatory environments Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Degree in Computer Science, Information Systems, Engineering, or Life Sciences. Preferred Qualifications: At least 5-8 years of domain knowledge in health and/or life sciences combined with Information Technology Proficiency in Python/PySpark development, Fast API, PostgreSQL, Databricks, DevOps Tools, CI/CD, GitLab, and Data Ingestion. Understanding, and preferably applied experience and knowledge, in data management and CTD document drafting Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. Experience driving a collaborative culture that values technical depth, accountability, and customer service. Strong problem-solving and analytical skills. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Understanding of ITIL processes and implementation. Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. Soft Skills: Excellent analytical and troubleshooting 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.

Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO) Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution. Provide technical input during project planning and scheduling of CQV activities. Track and report progress of CQV milestones, and support. Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures) Coordinate and interface with operations and quality assurance department, to develop supporting documentation, execution plans, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations. Initiate and manage validation deviations in the testing of development process and equipment functioning. Analyze the investigations to identify the root cause of the deviations to define a corrective action. Ensure efficient operation of the pharmaceutical equipment to corroborate the drug quality meets clients standards, GMP and FDA regulations. Perform design review to ensure the equipment is installed and operates according to the user requirement specification.

We are seeking an experienced Validation Engineer to join our team supporting a GxP platform that automates regulatory filings. This role is key to ensuring compliance, driving efficiency, and fostering innovation in data validation processes. You will collaborate closely with developers, business analysts, and stakeholders to validate technical requirements and support continuous improvements and automation within the program. Key Roles & Responsibilities Develop detailed test plans and validation strategies aligned with project specifications and regulatory requirements. Execute manual and automated testing including functional, regression, and performance tests. Document and report defects; collaborate with development teams to resolve issues effectively. Maintain comprehensive records of test cases, plans, and results to ensure full traceability and compliance with GxP standards. Validate test scenarios against acceptance criteria and customer expectations. Ensure all systems comply with regulatory requirements covering data integrity, traceability, and reliability. Identify and implement opportunities to enhance testing efficiency and automation. Evaluate and adopt new tools and technologies to improve automation capabilities. Keep validation documentation current and compliant with GxP and change management policies. Stay abreast of industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert validation support to optimize quality, efficiency, and cost-effectiveness for application development and troubleshooting. Basic Qualifications and Experience Master's degree with 1 to 3 years experience in Life Sciences, Biotechnology, Pharmacology, or Information Systems, OR Bachelor's degree with 3 to 5 years experience in the above fields, OR Diploma with 7 to 9 years experience in the above fields. Functional Skills Must-Have: Strong problem-solving skills with a passion for addressing complex challenges in drug discovery through technology. Experience working within Agile software development methodologies (Scrum). Excellent communication skills with the ability to confidently engage senior leadership. Proven experience writing requirements for modern web application development. Solid understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11. Proficiency in automation tools, data systems, and validation software. Good-to-Have: Expertise in scientific domain areas and associated technology requirements. Understanding of scientific software systems strategy, governance, and infrastructure. Familiarity with low-code/no-code test automation platforms. Experience with technical thought leadership. Ability to translate technical concepts into business language. Knowledge of DevOps, Continuous Integration (CI), and Continuous Delivery (CD) practices. Professional Certifications SAFe for Teams certification (preferred). Soft Skills Self-motivated with ability to work independently under minimal supervision. Strong mentoring and oversight capabilities; effective delegation skills. Excellent analytical skills including gap and fit assessments. Strong verbal and written communication skills. Ability to collaborate effectively with global, virtual teams. Capable of managing multiple priorities simultaneously. Team player focused on achieving shared goals. Strong presentation and public speaking abilities.

Role & responsibilities Must have good hands on experience in HPLC, electrophoretic test method. Should be able to handle liquid chromotography and relevent 21CFR softwares. Should have good hands on experience in cell based test method. Should be able to handle ELISA ,Microscope , basic QC instruments and revelent 21CFR software. Preferred candidate profile Jr-Executive 1-3 years experience in QC biologics Contact Person : Manasa (manasa.s@talent21.in)

Role & responsibilities 1. Preparation of Qualification documents for Pharmaceutical OSD Process Equipments. - URS, DQ, IQ, OQ, PQ 2. Execution of IQ, OQ & PQ of Process Equipments 3. Execution of modification projects 4. Review of Process Equipments layouts & associated utilities 5. Review of Process Equipment Vendor PFDs & PIDs 6. Preparation of URS for Process Equipment’s 7. Preparation of QRA & CR for modification projects 8. Creation of Maintenance plan, Calibration plan for Process equipment’s 9. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 10. Completion of all trainings assigned to role 11. Ensure integrity of data at workplace. 12. Ensure Good Documentation practices at workplace 13. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 14. Weekly meeting with cross functional team to meet project timeline. 15. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 16. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 17. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 18. Preparation of qualification document timely and Timely completion of project compliance action 19. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 20. Qualification documentation should prepare and execute with 100% accuracy without GXP error 21. All QMS actions should be completed within the assigned date. 22. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 23. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. company : Sando z Location : Mumbai (Kalwe Sight) share resumes to nedunuri.saikumar@manpower.co.in

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

Handling Following Type of Projects at Site as Leader: PLC System Validation Project - Execution Handle the site engineers as per the project given by Head. Co-ordinate between customers & Head/Senior. prepare the work reports related to project

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Sr Spec, IT RA Global Apps (Grade 17) Location: India (Remote/Hybrid Options Not Available) Company: Vantive Corporation About Vantive Vantive Corporation is a global leader in vital organ therapy healthcare, delivering innovative products, digitally enhanced solutions, and advanced services to support dialysis and ICU-based critical care Spun off from Baxter Kidney Care in February 2025, Vantive is committed to transforming kidney care and beyond, impacting over 1 million patient interactions daily in 100+ countries, We are seeking a Senior Specialist, IT QA RA Global Apps to serve as a System Owner and Functional Lead, responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle, This role requires hands-on experience with regulatory solutions such as Veeva RIM Vault or other Regulatory applications, Position Overview As the Sr Specialist, IT RA Global Apps, you will: Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements, Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions, Lead system validation, testing execution, and change management in a regulated environment, Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams, Act as the primary liaison between IT, business process owners, and external vendors, Key Responsibilities System Ownership & Governance Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements, Implement solutions that align with business needs and regulatory requirements, Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records, Ensure systems remain in a validated state throughout their lifecycle, Functional Business Analysis & Solution Design Gather, analyze, and document business requirements, workflows, and process improvements, Translate business needs into functional and technical specifications, Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications, Ensure solutions are scalable, compliant, and aligned with Vantives digital transformation strategy, Validation, Testing & Compliance Lead Computer System Validation (CSV) efforts, ensuring applications meet FDA, ISO 13485, and global regulatory standards, Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes, Manage risk assessments, audits, and regulatory inspections related to system validation and compliance, System Maintenance, Enhancements & Issue Resolution Oversee system upgrades, patches, and maintenance, recommending enhancements as needed, Manage issue triage, root cause analysis, and resolution for system defects, Work closely with business process owners to ensure applications align with operational needs, Coordinate with vendors and internal teams for system support and enhancements, Stakeholder Collaboration & Project Support Act as a key liaison between IT, Quality, Regulatory, and business stakeholders, Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives, Provide end-user training and support, ensuring smooth adoption of system enhancements, Assist with project management tasks, ensuring timely delivery of IT solutions, Technical Skills & Experience The Ideal Candidate Should Have a Strong Technical Foundation With Hands-on Experience In Enterprise Application Support, Configuration, And Deployment Key Technical Competencies Include Programming & Scripting: Basic understanding of Java, Dot net, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries, Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment, Validation & Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts Cloud Computing and Data Management: Familiarity with SaaS environments (e-g , Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions, Regulatory Domain: Hands-on experience with platforms like Veeva Vault QMS, TrackWise Digital Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc regulatory authorities, global registration of products, The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications, Soft Skills Analytical Thinking: Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance, Communication and Collaboration: Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders Ability to translate technical concepts into actionable insights for non-technical teams (e-g , explaining validation requirements to QA), Project Management: Basic project management skills to coordinate system upgrades (e-g , Veevas 3 annual releases), implementations, or process improvements Familiarity with methodologies like Agile or Waterfall, often used in IT projects, Attention to Detail: Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits, Qualifications & Experience Must-Have Qualifications 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences/Pharmaceutical/Medical Device industry, Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications, Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance, Ability to develop and execute test scripts, validation plans, and system documentation, Technical knowledge of SQL, system integrations, and application configuration, Bachelors degree in Computer Science, Information Systems, or a related field, Preferred Qualifications Experience with Veeva,Salesforce, AWS, Azure, or cloud-based environments, Basic project management experience (Agile, Waterfall, or hybrid methodologies), Strong problem-solving and analytical skills to address complex system issues, Excellent communication and stakeholder management skills, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Consultant, IT EHS/QA Apps About Vantive Vantive Corporation is a global leader in vital organ therapy healthcare, delivering innovative products, digitally enhanced solutions, and advanced services to support dialysis and ICU-based critical care Spun off from Baxter Kidney Care in February 2025, Vantive is committed to transforming kidney care and beyond, impacting over 1 million patient interactions daily in 100+ countries, We are seeking a Consultant, IT EHS/QA Apps to serve as a Technical and Functional Lead, responsible for ensuring EHS and Quality global applications meet business requirements and remain in a validated state throughout their lifecycle, This role requires hands-on experience with quality solutions such as TrackWise, LabVantage LIMS, Benchmark SaaS, or other Quality & Regulatory applications, Position Overview As The Consultant, IT EHS/QA Apps, You Will Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements, Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions, Lead system validation, testing execution, and change management in a regulated environment, Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams, Act as the primary liaison between IT, business process owners, and external vendors, Key Responsibilities Technical Leadership & System Support Lead the technical configuration, maintenance, and optimization of EHS and Quality systems like TrackWise (QMS), LabVantage LIMS, and Benchmark SaaS Provide technical expertise in AWS-based cloud solutions, SaaS platforms, and on-prem EHSS application architectures, Support the implementation of EHSS dashboards, analytics, and reporting tools to provide real-time compliance insights, Analyze, troubleshoot, and resolve technical issues, ensuring high availability and performance of applications, Work closely with business stakeholders, vendors, and IT teams to align solutions with business needs, Application Development & Integration Manage and support EHS and Quality applications used for compliance tracking, incident management, occupational health, and environmental sustainability reporting Support and oversee application enhancements, upgrades, and deployments in compliance with IT governance policies, Collaborate with developers, system architects, and business analysts to design and implement solutions that integrate with other enterprise systems (ERP, HRIS, and BI tools), Ensure seamless data flow between systems through API integrations, middleware, and ETL processes, System Ownership & Governance Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements, Implement solutions that align with business needs and regulatory requirements, Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records, Ensure systems remain in a validated state throughout their lifecycle, Functional Business Analysis & Solution Design Gather, analyze, and document business requirements, workflows, and process improvements, Translate business needs into functional and technical specifications, Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications, Ensure solutions are scalable, compliant, and aligned with Vantives digital transformation strategy, System Administration & Continuous Improvement Proactively monitor, maintain, and optimize application performance, security, and compliance, Identify and recommend improvements, automation opportunities, and best practices to enhance system efficiency, Train and mentor junior IT team members and provide technical leadership in the EHSS & Quality IT space, System Maintenance, Enhancements & Issue Resolution Oversee system upgrades, patches, and maintenance, recommending enhancements as needed, Manage issue triage, root cause analysis, and resolution for system defects, Work closely with business process owners to ensure applications align with operational needs, Coordinate with vendors and internal teams for system support and enhancements, Stakeholder Collaboration & Project Support Act as a key liaison between IT and EHSS and Quality business stakeholders, Support global Quality and EHSS IT projects, including new system implementations and digital transformation initiatives, Provide end-user training and support, ensuring smooth adoption of system enhancements, Assist with project management tasks, ensuring timely delivery of IT solutions, Technical Skills & Experience The Ideal Candidate Should Have a Strong Technical Foundation With Hands-on Experience In Enterprise Application Support, Configuration, And Deployment Key Technical Competencies Include Programming & Scripting: Basic understanding of Java, Dot net, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries, Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment, Validation & Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts Cloud Computing and Data Management: Familiarity with SaaS environments (e-g , Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions, Regulatory Domain: Hands-on experience with platforms like TrackWise Digital, LabVantage LIMS Understanding of regulatory process and submissions, including submission registration and publishing, promotional materials, etc egulatory authorities, global registration of products, The candidate should be able to collaborate with developers, business analysts, and cloud teams, ensuring seamless deployment, maintenance, and optimization of critical Quality and Regulatory applications, Soft Skills Analytical Thinking: Ability to analyze complex business requirements, map them to system capabilities, and identify gaps or risks Problem-solving skills to troubleshoot system issues while maintaining regulatory compliance, Communication and Collaboration: Strong verbal and written communication to liaise between IT, quality assurance (QA), regulatory affairs, and business stakeholders Ability to translate technical concepts into actionable insights for non-technical teams (e-g , explaining validation requirements to QA), Project Management: Basic project management skills to coordinate system upgrades (e-g , Veevas 3 annual releases), implementations, or process improvements Familiarity with methodologies like Agile or Waterfall, often used in IT projects, Attention to Detail: Precision in documenting system changes, validation protocols, and SOPs to withstand regulatory audits, Qualifications & Experience Must-Have Qualifications 8+ years of experience in IT application support, preferably in regulated healthcare, pharma, life sciences, or EHSS industries, Hands-on experience with applications such as Benchmark Gensuite, TrackWise (QMS) and LabVantage LIMS or other EHSS/Quality applications, Strong knowledge of AWS (including cloud security, deployment, and infrastructure management), Experience with SaaS platforms, system integration, APIs (REST/SOAP), and middleware solutions, Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance, Ability to troubleshoot complex technical issues, perform root cause analysis, and provide long-term solutions, Excellent analytical, communication, and problem-solving skills, Certifications in AWS, EHSS/Quality systems, or ITIL are a plus, Bachelors or Masters degree in Computer Science, Information Systems, or a related field, Preferred Qualifications Experience with SQL, Dot net, Java, or scripting languages for system troubleshooting and automation, Familiarity with ITSM tools (e-g , ServiceNow) and Agile methodologies, Knowledge of business intelligence and reporting tools (e-g , Tableau, Power BI) for Quality and EHSS applications, Experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments, Basic project management experience (Agile, Waterfall, or hybrid methodologies), Strong problem-solving and analytical skills to address complex system issues, Excellent communication and stakeholder management skills, Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice, Show more Show less

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality Assurance Manager Regulatory Compliance Ensure software and AI systems comply with USFDA (21 CFR Part 11, 820), GDPR, HIPAA, ISO 13485, and other global standards. Stay updated on evolving healthcare AI regulations and integrate them into QA practices. Prepare for and support audits by regulatory bodies, clients, and third parties. Computer System Validation (CSV) Lead development and maintenance of CSV protocols (IQ, OQ, PQ) for software and AI systems. Ensure validation documentation aligns with GxP standards and is audit-ready. Collaborate with IT and development teams on system updates and new features. QA Strategy & Leadership Develop and implement QA strategies using risk-based validation approaches. Manage and mentor QA teams, fostering a quality-focused culture. Monitor KPIs for software and AI quality and compliance. Process Improvement Create and maintain SOPs for QA, CSV, and AI validation. Conduct root cause analysis and implement CAPAs. Drive initiatives to improve system performance, security, and reliability. Cross-Functional Collaboration Partner with product, development, and AI teams to integrate quality into the SDLC. Translate client and stakeholder requirements into actionable QA plans. Support implementation and post-deployment activities to ensure satisfaction. Risk Management Conduct risk assessments per ISO 14971 and ICH Q9, addressing AI-specific risks (e.g., model bias). Mitigate risks related to data integrity, security, and compliance. Training & Documentation Provide training on QA, CSV, AI validation, and compliance. Maintain thorough documentation of validation activities, audit trails, and quality records. Qualifications Minimum of 10+ years of experience in quality assurance, with at least 5 years in a managerial role within a clinical trial software, CRO, Pharma, Biotech, or Medtech environment. Extensive experience with Computer System Validation (CSV) in a regulated industry. Proven track record of managing QA for software used in global clinical trials. Education: Bachelor's degree in Life Sciences or a related field. Advanced degree (e.g., Masters) or certifications (e.g., ASQ CQA, ISTQB, Six Sigma) preferred. Technical Skills: In-depth knowledge of USFDA regulations (21 CFR Part 11, Part 820), GDPR, HIPAA, ICH-GCP, and ISO standards (e.g., 13485, 14971), including AI-specific guidelines. Proficiency in CSV methodologies and tools (e.g., GAMP 5 framework). Familiarity with clinical trial software platforms (e.g., EDC, IWRS, eTMF, CTMS) and AI-driven solutions in clinical research. Soft Skills: Strong leadership and team management abilities. Excellent problem-solving, analytical, and decision-making skills. Exceptional communication skills, with the ability to liaise with technical teams, AI specialists, regulators, and clients. Detail-oriented with a proactive approach to quality and compliance. Why Join Us? Impactful Work : Contribute to cutting-edge AI-enabled solutions that accelerate clinical trials and improve global healthcare outcomes. Innovative Culture : Be part of a dynamic team that embraces new ideas, challenges the status quo, and drives innovation. Growth Opportunities : Access professional development opportunities in a rapidly growing company committed to employee success. Work-Life Balance : Enjoy a supportive work environment with flexible work arrangements.

Mechanical Engineering - (Associate Manager/ Manager) Role & responsibilities Manage/support multiple projects that are ranging from new product development to life cycle management/ sustaining engineering. Defines design requirements and development specifications based on customer or user requirements. Contributes to development and documentation of mechanical system architectures. Contributes to ideations, troubleshooting and problem solving efforts related to new product development and sustaining projects. Hands-on experience in Design History File compilation / Technical file documentation. Good understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance Creates and develops designs of mechanical assemblies, mechanisms, and component parts for electro-mechanical medical devices meeting set requirements. Performs in-depth mechanical analysis and calculations including kinematic analysis, tolerance analysis, structural analysis- FEA to evaluate design robustness and to ensure consistent performance and safety of critical functions. Ensures successful integration of mechanical design elements with electrical and consumable components. Build and test design concepts and Engineering prototypes for verification. This includes compiling and presenting data to support design verification of new products in accordance with company and regulatory requirements. Lead activities related to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Must be able to participate in design reviews for reviewing the design changes & seek management approval to move forward. Preferred candidate profile A graduate or a postgraduate in Mechanical or related engineering and having minimum 8 years related experience. Exposure to medical device lifecycle management preferred. Hands on experience in electromechanical product development, preferably medical devices. Knowledge and experience using CAD systems for mechanical design and analysis (Solidworks preferred). Knowledge of standards such as IEC 60601, ANSI and ASTM preferred. Knowledge on Risk assessment, Root cause analysis procedures, DFMEA, PFMEA, ISO, etc is desirable. Knowledge of DFM & DFA with respect to ease of manufacture and assembly. Knowledge of Design and manufacturing Engineering of metal and plastic parts is required. Excellent communication skills- Written and oral such as Technical documentation, Presentation skills.

Validation Engineer I What you will do Let’s do this. Let’s change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. 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: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Industry Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11. Proficiency in automation tools, data systems, and validation software. Preferred Qualifications: Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes Knowledge of the Disclose application from Citeline and docuBridge from Lorenz Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams 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 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 and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

QUALITY ASSURANCE & VALIDATION Responsible for development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Interfaces with customers and vendors representing company as Quality champion. Formulates and maintains quality assurance objectives complementary to corporate policies and goals. Designs and implements quality assurance training programs to key personnel in conjunction with managers. Prepares and maintains control plans and revises/audits processes, responds to customers quality concerns. Manage client and regulatory authority audits Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for entire organization Author or Review validation documentation (plans, protocols, test suites, reports, etc.). Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented. Coordinates client specific validation activities with practice leads. Enforce QA requirements for IT quality systems with potential GxP impact. Support GxP decisions/strategies during validation projects. Document applicable deviations and documentation anomalies for computer systems undergoing validation. Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met. Review requirements, traceability matrices, test suites and test executions. Travel involved. Other duties as assigned. KRA spread: QMS and corporate Quality management: 60% Validation: 40% Location - Madhapur, Hyderabad, Telangana, India

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of employee performance on the job. > Coordinating with other departments to ensure that production runs smoothly Ensuring that all safety regulations are followed in the production area. Managing all aspects of production, including hiring workers, ordering supplies, maintaining production schedules, and overseeing equipment maintenance. Reviewing production schedules and work orders to ensure that production goals are being met in handling QMS activities. for more details please reach out Venkat -9381915043 or please share your CV to venkateswara.k@talent21.in

Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus: Excellent communication skills. Ability to work as a team player in a consulting environment. Proficiency with MS Office tools. Documentation management Strong Project Management experience (preferred but not required)

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.