Validation Project Lead

2 days ago


London, Greater London, United Kingdom Resolian UK Full time
Job Description
  • Oversight and Compliance:
    • Responsibility for IT CSV oversight in GxP computerized systems.
    • Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5).
    • Handling deviations, CAPAs, and change controls.
  • Documentation and Review:
    • Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
  • Collaboration:
    • Ability to work independently on validation projects but also collaborate with cross-functional teams (IT, QA, Operations).
    • Strong communication, problem solving, and leadership in CSV processes.
  • Audit and Regulatory Support:
    • Supporting external audit programs for vendors.
    • Interfacing with regulatory agencies.
  • Strategy and Improvement:
    • Developing and implementing CSV strategies, policies, and procedures.
    • Reviewing and approving validation documentation.
    • Resource coordination, monitoring, and tracking of validation activities.
    • Staying current with industry trends and regulatory changes.
    • Continuous improvement of the CSV process.
    • Flexibility and adaptability in a changing regulatory environment.


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