- 8 years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry. - Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems. - Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports. - Expertise in ensuring regulatory compl…
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