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Computer System Validation


Vaisesika


Location

Delhi | India


Job description

Vaisesika is looking for Computer System Validation profiles. Experience : 5+ years Notice : Immediate Location : Remote

Key Responsibilities:

Should have 3 to 10 years’ experience in computer system validation or testing experience in the Life sciences domain.

Provide application validation expertise on GxP products Good Knowledge of 21 CFR Part11, Annex11 and GAMP5 Be accountable for authoring key CSV deliverables – URS/FRS, Validation Plan, RTM and Validation Summary Report Requirements Analysis and Functional Risk Assessment, Profiling and Mitigation in collaboration with the SME Reviewing and authoring of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) Closely work with clients and product owners to support implementation and resolve product issues.


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