Job Description

• 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.

• 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.

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