Requirements:

Min 5 years of CSV experience. experience supporting validation of GxP GEN AI based solutions is a major plus experience supporting mergers/acquisitions/divestitures is a major plus Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures. Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously. Ability to provide Validation guidance, timely reviews, and escalations to TQ management.