Pragnesh Patel
CAPA & Change Control Coordinator | Pharmaceutical QA Professional | cGMP Compliance | Document & MBR Management
- Role
- Senior Quality Assurance Specialist at Ferring Pharmaceuticals
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Pragnesh Patel
Senior Quality Assurance & Compliance Specialist with 7+ years of experience in…
Experience
Senior Quality Assurance Specialist
Dec 2024 — Present
Review, track, and ensure timely closure of CAPAs and Change Controls in eQMS.• Facilitate cross-functional RCA meetings; define corrective/preventive actions and monitor CAPA effectiveness.• Author/revise SOPs, work instructions, and procedural documents supporting CAPA and Change Control systems.• Manage Master Batch Record (MBR) lifecycle, including creation, revision, and approval in line with CAPA/Change Control.• Conduct periodic reviews of SOPs, MBRs, and controlled documents to maintain regulatory and operational compliance.• Maintain GxP document control system including versioning, archival, and retrieval processes.• Train personnel on CAPA, Change Control, MBR handling, and documentation SOPs.• Drive continuous improvement by identifying trends and enhancing documentation workflows.• Support internal/external audits with detailed CAPA histories and compliance records.• Partner with manufacturing teams to ensure deviation prevention and real-time issue escalation.• Conduct risk assessments on quality events, providing mitigation strategies.• Mentor junior QA associates on documentation and audit readiness best practices
Education
Ssvps
Bachelor of Engineering, Automobile/Automotive Mechanics Technology/Technician
2006 — 2010
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