CQV Consultant

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 (1014 years) based in India who have hands-on expertise in commissioning, qualification and validation of:

Active Pharmaceutical Ingredients (API) equipment

Oral Solid Dosage (OSD) formulation equipment

Sterile / Injectable manufacturing equipment

Utility Systems (HVAC, PW, WFI, Clean Steam, Compressed Air, Nitrogen)

Manufacturing facility qualification & cleanroom validation

What Were 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 environments
• Ability to handle client-facing roles
• Practical experience in documentation & execution not just review

Bonus if you have experience in:

• Kneat and Veeva Systems
• Cleaning validation
• Process validation / PPQ
• CSV / Automation systems
• Greenfield / Brownfield expansion projects

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