Job Description: We need: A senior CSA (Computer Software Assurance) SME with GAMP 5, GxP and 21 CFR Part 11..., reviewing, and addressing CAPAs as well as experience with Data Integrity and ALCOA+ is a plus. The CSA Validation SME...
(CSA). Solid knowledge of GAMP 5 and 21 CFR Part 11 standards. Prior experience in GxP or life sciences industries... from system stakeholders on deliverables. Draft and execute GxP Assessments, Risk Assessments, Validation Plans, Test Plans...