Hybrid in South San Francisco, California
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Today
QA/CSV SME MUST haves - Clinical Systems Validation (Veeva eTMF, Medidata Rave, Clinical Data Repositories) Provide QA oversight for Computer System Validation (CSV) activities across GxP-regulated clinical and biopharmaceutical systems, ensuring compliance with FDA 21 CFR Part 11, GAMP 5, and applicable regulatory requirements.Review and approve validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ
Easy Apply
Contract, Third Party
65 - 75

















