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Validation Specialist

Katalyst Healthcares & Life Sciences

  • Thousand Oaks, CA
  • 30+ days ago

    Highlights

    Support audits, inspections, and validation testing activities. Responsibilities: Lead validation activities for Labware LIMS 8 implementation.

    Numbers & Facts

    LocationThousand Oaks, CA

    Description

    Responsibilities:
    • Lead validation activities for Labware LIMS 8 implementation
    • Author and review IQ/OQ/PQ, RTM, and validation documentation
    • Ensure compliance with GXP, CSV, and regulatory standards
    • Support audits, inspections, and validation testing activities.
    Required Skills:
    • Labware LIMS (Labware 8 Preferred)
    • Computer System Validation (CSV)
    • GXP / GMP Environment
    • GAMP 5 & Regulatory Compliance
    • IQ / OQ / PQ Documentation
    • Requirements Traceability Matrix (RTM)
    • Validation Strategy & Execution
    • Audit Readiness & Inspection Support
    • Deviation, CAPA & Change Control Management
    • Laboratory Systems & Enterprise GMP Systems Validation.
     

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