Computer System validation Engineer

Hi,

Title:Computer System validation Engineer

Compute System Validation(CSV) with R&D Knowledge



Qualification: 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

Knowledge, Experience and Skills:

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CORE CSV

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