Computer System Validation Specialist - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
- Possess hands-on experience with the Veeva Vault Quality Docs 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.
- 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 Quality Docs 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.
Source : Katalyst Healthcares & Life Sciences