Senior Validation Lead

21 hours ago

Bengaluru, Karnataka, India Sigma-Aldrich Chemicals Private Limited Full time

We are looking for a strong and experienced Senior Validation Lead to guide and execute the Computerized System Validation/Assurance of IT systems and projects within our Research and Development (R&D) division. This role is critical in ensuring that our IT systems comply with regulatory requirements and industry standards, thereby supporting our mission to deliver high-quality pharmaceutical products for patients.

The ideal candidate will have extensive experience in FDA 21 CFR Part 11, EU Annex 11, GVP regulations, and GAMP GxP computerized systems validation. Familiarity with the ISPE GAMP AI Guide, AI Guidance for GxP environments, and the EU AI Act will add additional value. The candidate should also possess a solid understanding of Agile development under GxP conditions, act and decide risk based and strengthen this mindset within the team.

In this role, you will guide IT Vendor Management and IT Service Delivery with your regulatory expertise, providing input, support and address IT Vendor audits. You will also guide and supervise corrective and preventive actions (CAPA) as part of the deviation management and continuous improvement process. Collaborating closely with project teams, you will ensure compliance throughout the project lifecycle. With this you are responsible for Audit and Inspection readiness, present and explain compliance documentation and processes during internal audits and external inspections.

Key Responsibilities:

  • Lead and manage the validation activities for R&D IT systems, ensuring compliance with regulatory guidelines (e.g., FDA, EMA) and internal policies.
  • Develop and implement validation strategies, plans, and documentation (e.g., URS, IQ, OQ, PQ) for new and existing systems.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and R&D, to ensure seamless integration of validation processes into project timelines.
  • Conduct risk assessments and gap analyses to identify validation needs and ensure compliance throughout the system lifecycle.
  • Provide expert guidance and support during audits and inspections related to validation activities.
  • Mentor and train team members on validation best practices and regulatory requirements.
  • Stay current with industry trends, regulations, and technologies related to IT system validation.
  • Prior hands on experience on validating Veeva Vault applications is mandatory.

Qualifications:

  • Bachelor's degree in Computer Science, Life Sciences, Engineering, or a related field; advanced degree preferred.
  • Minimum of 8 years of experience in IT system validation within the pharmaceutical or biotechnology industry.
  • Strong knowledge of international GxP regulations, validation methodologies, and risk management principles.
  • Proven experience in leading validation projects and managing cross-functional teams.
  • Excellent communication, problem-solving, and organizational skills.
  • Ability to work independently and collaboratively in a fast-paced environment

  • Validation Lead

    1 week ago

    Bengaluru, Karnataka, India Merck KGaA Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Validation Lead

    2 weeks ago

    Bengaluru, Karnataka, India The businesses of Merck KGaA, Darmstadt, Germany Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Work Your Magic with us  Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix...

  • Battery Validation Lead

    2 weeks ago

    Bengaluru, Karnataka, India, Karnataka Zeno Full time

    Zeno is seeking a Battery Validation Lead to establish and lead validation efforts for Zeno’s battery systems. Location: Bengaluru – Work from Office (5 days a week)Start Date: ImmediateAbout ZenoAn unprecedented energy transition has begun. To meet 2040 net zero goals, over 2 billion electric two-wheelers (motorcycles) must be sold and $11 trillion in...

  • Validation Lead

    5 days ago

    Bengaluru, Karnataka, India, Karnataka Mareana Full time

    Job Description – Validation Lead Location: BangaloreType: Full-TimeExperience: 8+ YearsRole OverviewWe are seeking a highly skilled CSV Validation Lead to manage Computer System Validation and compliance governance across our GxP-regulated enterprise applications. The ideal candidate must have strong hands-on experience validating enterprise applications...

  • Validation Lead

    2 weeks ago

    Bengaluru, Karnataka, India Livspace Full time ₹ 6,00,000 - ₹ 9,00,000 per year

    About UsLivspace is Asia's largest and fastest-growing home interiors and renovation platform. Leveraging its proprietary technology, the company delivers end-to-end home interior and renovation solutions, encompassing modular solutions, furniture, false ceilings, soft furnishings, décor, civil works, and more. The company serves homeowners across diverse...

  • Senior Validation Engineer

    2 weeks ago

    Bengaluru, Karnataka, India L&T Semiconductor Technologies Full time ₹ 7,50,000 - ₹ 15,00,000 per year

    Senior Validation EngineerExperience : yrsJDKnowledge of one or more Protocols: PCIe, LPDDR, SPI, USB, AXI, Lin CAN , ETHERNET, MMI DSI/CSIKnowledge of ARM and/or x86 SoC Architecture with internal understanding of complete BOOT Process.Strong experience in C programming language and Assembly Language.Free-RTOS experienceNetworking / Wifi stack in Linux...

  • Senior Clinical Validation Analyst

    2 weeks ago

    Bengaluru, Karnataka, India IRE Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Senior CVA, Chennai, Office basedICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Clinical Validation Analyst to join...

  • Senior Computer Systems Validation Specialist

    2 weeks ago

    Bengaluru, Karnataka, India The Emmes Company, LLC Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Overview:Emmes Group: Building a better future for us all.Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into...

  • Senior Principal AI SoC Validation

    7 days ago

    Bengaluru, Karnataka, India Graphcore Full time

    GraphcoreSenior Principal AI SoC Validation (Bring-up lead)Graphcore is a globally recognised leader in Artificial Intelligence computing systems. The company designs advanced semiconductors and data centre hardware that provide the specialised processing power needed to drive AI innovation, while delivering the efficiency required to support its broader...

  • Senior Validation Engineer

    2 weeks ago

    Bengaluru, Karnataka, India, Karnataka L&T Semiconductor Technologies Full time

    Senior Validation EngineerExperience : 7 - 15 yrs JD Knowledge of one or more Protocols: PCIe, LPDDR, SPI, USB, AXI, Lin CAN , ETHERNET, MMI DSI/CSI Knowledge of ARM and/or x86 SoC Architecture with internal understanding of complete BOOT Process.Strong experience in C programming language and Assembly Language.Free-RTOS experienceNetworking / Wifi stack in...