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Compute System Validation Engineer

Karwell Technologies

  • Wilmington, DE
  • 1 day ago

    Highlights

    Roles & Responsibilities: 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes. High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP.

    Numbers & Facts

    LocationWilmington, DE

    Description

    Roles & Responsibilities :
    • 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
    • Authoring of URS/FS, protocols, final reports, validation plan/report
    • High-level understanding of Veeva Vault suits
    • Risk-based testing aligned to CSA fundamentals
    • High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

    Education & Experience :

    • Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
    • Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system

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