Manoj Kumar Verma — GMP, QMS & CQV Consultant

I've spent 25 years across the pharmaceutical, biopharmaceutical, and vaccine industries, building two complementary strengths: leading Quality Assurance and Quality Management Systems from inside manufacturing organizations, and delivering Commissioning, Qualification & Validation (CQV) as an external specialist on pharma project sites.

On the QA and QMS side, I've served in Quality Assurance departments across multiple manufacturing organizations — including Panacea Biotec, B.V. Biologicals, Lupin Biotech, Wockhardt, and Vital Healthcare — progressing from Senior Scientific Officer through to Manager of the Quality Unit. In these roles I designed and managed quality systems covering CAPA, deviation, change control, OOS, and self-inspection; maintained Tier I–III documentation from Quality Manuals and Site Master Files through to SOPs, BMRs, and BPRs; and personally supported inspections by the USFDA, WHO-Geneva, CDSCO, and ISO 13485 certification bodies, with successful outcomes. More recently, I've managed QMS to ISO 9001:2015 and ICH Q10 in a technical services environment.

On the CQV side, I've led validation programs for facilities, black and clean utilities, process equipment, and computerized systems, from URS through PQ, and authored apex-level governance documents including CQV Master Plans, System Level Impact Assessments, and Quality Risk Assessments. That work spans oral solid dose, oral liquid, injectable/sterile, biologics, and vaccine environments, and has taken me across India, Thailand, Vietnam, and the UK — including leading CQV execution at a government-owned pharmaceutical manufacturing site in Southeast Asia, commissioning and qualification of a sterile manufacturing facility in Newcastle, UK, and a direct role in the international technology transfer of a Hepatitis-B r-DNA vaccine process from Cuba to India.

Having managed quality from inside the manufacturing operation as well as delivered it as an external validation specialist, I bring a practical, risk-aware perspective grounded in ICH Q7, EudraLex Vol. 4 (EU GMP), 21 CFR Parts 11/210/211/820, GAMP 5, ASTM E2500, ASME BPE, ISO 14644, and the ISPE Baseline Guide Volume 5 — Pharma GXP Global Consulting is where that perspective is now available directly to your organization.