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    Sr. Validation Engineer(CSV) - Princeton, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Princeton, United States

    4 weeks ago

    Default job background
    Description
    Responsibilities :
    • Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
    • Should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies
    • Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
    • Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exce
      ption reports which identify defects or issues during test execution Review vendor documentation
    Requirements:
    • Requirement Specification document review and approvals
      •
    • System Implementation Plan Review
    • System Implementation Summary Report Review
    • Review and Pre-Approve ST/UAT Test Scripts in ALM
    • Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
    • Post Execution Review and Post Approvals in ALM
    • CR Implementation Approvals
    • Retirement Plan Review
    • Retirement Summary review Deliverables:
    • Requirement document
    • Validation/Test Plan
    • Requirement Traceability Matrix
    • Change Requests
    • Impact assessment document
    • Test/Validation Summary Report
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