CQV Consultant (Freelance)

We are building a high-caliber CQV (Commissioning, Qualification and Validation) team for Pharma and Biotech facilities that will support global pharma projects, including multinational clients. You will work on complex validation programs, regulatory-facing projects, and large-scale facility qualifications at Global Level.

Experienced professionals (10-14 years) based in India who have hands-on expertise in commissioning, qualification and validation of:

Active Pharmaceutical Ingredients (API) equipmentOral Solid Dosage (OSD) formulation equipmentSterile / Injectable manufacturing equipmentUtility Systems (HVAC, PW, WFI, Clean Steam, Compressed Air, Nitrogen)Manufacturing facility qualification & cleanroom validation

What We're Looking For:Expert in preparation and/or review of all levels of CSV validation documents including:Validation Plans, URS, IRA, PVP, FRA, FDS, IQ, OQ and PQ, Traceability Matrices, Gap assessments and Risk Analysis, VSRs, Change Controls, Deviations, CAPA and GAP assessments. Prepare and Review PRR, schedules, System Retirement Plan with their summary Report.Understanding of Lifecycle validation (risk-based approach preferred)Exposure to USFDA / EU GMP regulated environmentsAbility to handle client-facing rolesPractical experience in documentation & execution - not just review

Bonus if you have experience in:Kneat and Veeva SystemsCleaning validationProcess validation / PPQCSV / Automation systemsGreenfield / Brownfield expansion projects

Educational Qualification: BE/B. Tech./M. Tech./B. Pharm/M.Pharm