Job Description: We need: A senior CSA (Computer Software Assurance) SME with GAMP 5, GxP and 21 CFR Part 11 standards. Candidates need to have previous experience in the GxP industry, or a life sciences industry is required as well as technical competency in FDA regulations. They must draft and execute the GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary. Candidates must have expertise in generating, reviewing, and add…