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GMP CSV Consultant: Systems Validation & IT Controls
Job in
Edison, Middlesex County, New Jersey, 08818, USA
Listed on 2026-07-20
Listing for:
Lupin Pharmaceuticals
Full Time
position Listed on 2026-07-20
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Lupin Pharmaceuticals is hiring a CSV Consultant to support validation across GMP labs and manufacturing at the Somerset, New Jersey site. You will manage multiple validation projects, implement data integrity and IT controls, and ensure compliance with 21 CFR Part 11 and GAMP 5, coordinating with cross‑functional teams and vendors.
Responsibilities include documenting URS/FRS, IQ/OQ/PQ/UAT, RTM, and validation summaries while maintaining systems in a validated state.
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