Manage and execute Computer System Validation (CSV) activities for GMP-regulated equipment, utilities, automation, and computerized systems across Tablet, Capsule, and PFS facilities, ensuring compliance with GAMP 5, 21 CFR Part 11, Data Integrity, EU GMP, MHRA, and WHO GMP requirements.
Key Responsibilities:
- Prepare and execute CSV lifecycle documents (URS, FS, DQ, FAT, SAT, IQ, OQ, PQ, VSR, VMP).
- Validate current computerized systems, equipment upgrades, software changes, and automation/SCADA systems.
- Conduct periodic reviews, compliance assessments, and revalidation activities.
- Manage change controls, impact assessments, and lifecycle documentation.
- Ensure regulatory compliance and support audits/inspections.
- Maintain validation records and coordinate with QA for approvals.
- Collaborate with Engineering, QA, IT, Production, Automation, and Project teams.
Systems Exposure: PLC/SCADA, BMS, HVAC, Water Systems, MES, EMS, Track & Trace, Laboratory Systems, PFS Equipment, Compression, Capsule Filling, Coating, and Packaging Lines.
📌 Computer System Validation Engineer (Pune)
🏢 Emcure
📍 Pune