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...
). 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...
(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...