Responsibilities: Requires thorough understanding of System Development Life Cycles for FDA regulated applications Must be experienced in developing Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. Requires thorough knowledge of US CFR 21 Part 11 regulations. Experienced with high volume application testing environment. Experience with automated Software Testing tools is a plus.
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