CSV Validation Test Lead (GxP)
Location
Princeton, NJ | United States
Job description
- Computer System Validation and Quality Lead with work experience in GxP-regulated areas in the Life Science industry
- Proven track record in delivering excellence, on-time delivery, and ensuring the quality of deliverables by implementing QA best practices, regulations, and GDP guidelines.
• Specialist in Pharma and Medical Device environment with expertise in Computer System Validation (CSV), Quality Assurance, and Process Guidance. Testing and Technical Documentation in Compliance with global regulations, industry standards, and best practices.
• Skilled at CSV of – Clinical Trial systems, Pharmacovigilance and R&D systems, Enterprise level Quality Systems, and various other custom-built and COTs products used across the LS industry.
• Experienced in SDLC compliance validation for GxP computerized systems and applications with regulatory requirements and controls associated with CFR 21 FDA Part 11, Annex 11 and EU GMP Annex 1
• Excellence in developing Quality Management Systems (QMS), including SOP, Working Practices, and Templates for Pharmaceutical companies with the guidance of Quality Teams.
• Participated in QualityRisk Assessment (Regulatory, Data Integrity, General Data Protection Regulation (GDPR) Assessment, and Cloud) and documentation as per GAMP 5 guidelines.
• Well-versed with FDA’s latest guideline, i.e., Computer System Assurance (CSA)
• Works in Validation Planning and Execution for CSV projects. Well-versed in authoring, reviewing, and approving validation documents such as Validation Plan/Report, Data migration Plan/Report, Technical Functional Risk Assessments, Validation/Qualification Protocols (IQ, OQ, UAT, and PQ), Traceability Matrix, Validation Summary reports, etc.
• Practices Data Integrity across GxP towers and computerized systems
• Performs Deviation Management, CAPA management, and Effectiveness Check Reports.
• Follows a risk-based approach in project execution.
• Works in Methodologies: Agile, Waterfall, V-Model
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