Responsibilities: Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owners, IT teams, vendors, and Business Analysts to define validation requirements and plans. Provide oversight and training related to validation activities to multi-functional teams. Coordinate and support User Acceptance Testing (UAT) and Data Migration Activities. Review defects and collaborate with IT/Vendors for resolution, scheduling defect triage meetings as necessary. Act as the subject matter expert (SME) for CSV activities and maintain expertise in the CSV domain. Requirements: Bachelor's or master's degree in engineering or a related field (equivalent education and work experience may be considered). 7+ years of experience in a Computer System Validation role within the pharmaceutical, biotech, or other regulated industries. Demonstrated experience in software quality assurance processes, Software Development Life Cycle (SDLC) methodologies, IT change management, documentation, verification, and validation techniques. Hands-on experience validating and maintaining the Veeva Vault QualityDocs system and data migration. Understanding of GAMP 5 techniques, software industry standards, and their implications on internal procedures and software quality. Working knowledge of FDA Quality System Regulation, 21 CFR Part 11 and Annex 11 regulations. Katalyst Healthcares and Life Sciences
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