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    Computer Systems Validation Lead - San Francisco, United States - RxCloud

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    About the job Computer Systems Validation Lead

    • At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable validation strategies, documents, and perform document reviews
    • At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments
    • Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
    • Experience with FDA 21 CFR Part 11
    • Experience with the validation of Enterprise systems SAP and/or MES system Preferred. Validation of Life sciences systems such as Veeva, Trackwise, Argus, Clnical, Quality systems highly desired.
    • Broad understanding of the test management Tools, including experience and knowledge Microfocus ALM, ValGenesys etc preferred.
    • Knowledge and experience around CSA highly preferred.

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