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Katalyst CRO Linkedin · Posted 25d ago

Computer System Validation Engineer

Wilmington

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Indexed 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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