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 systemsSAP and/or MES system Preferred. Validation ofLife sciences systems such as Veeva, Trackwise, Argus, Clnical, Qualitysystems highly desired.
Broad understanding of the test managementTools, including experience and knowledge Microfocus ALM, ValGenesysetc preferred.
Knowledge and experience around CSA highly preferred.