Vinod Kumar

GxP Advisor

Vinod is a Quality and Regulatory leader with over 15 years of exposure under GxP operations with various Pharmaceuticals, Biopharmaceutical, Medical Device, and Cannabis companies like Pfizer, Ranbaxy, Daiichi Sankyo, Intas (Apotex), Unichem, Med-Life Discoveries, Chromtec, and Northern RNA. Vinod is expertise in developing quality & compliance strategies, quality performance & cost benchmarking, quality management system (QMS) optimization, and delivery of compliance & regulatory management services fostering a robust quality culture. Capable of achieving a significant reduction in quality-related costs through superior quality and flawless compliance.

Vinod is skilled in preparing all regulatory dossiers related to product quality, facility compliance, cGMP compliance, new facility & product validation & qualification, coordination with DGCI, and managing compliance audits by multiple regulators – USFDA, Health Canada, ANVISA, MHRA, MCC, EU regulators, TGA, IMB, and WHO.

Vinod has experience contributing to numerous projects for setting up new manufacturing facilities from design to end-user training. Capable of coordinating equipment procurement, installation, validation & qualification, batch release, and end-user support. Vinod is expertise in the design, development & delivery of training programs & modules to build competency, skills & knowledge on current technologies, quality management systems, and regulatory compliance.

Vinod has hosted over 50+ regulatory inspections.

Vinod holds a master’s degree in Pharmaceutical Chemistry and a bachelor’s degree in Zoology, Botany, and Chemistry (Hons.). Vinod is a certified Method1 investigator and GxP auditor.

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Saskatchewan, CanadaFrankfurt, Germany

Toronto, CanadaNorth Carolina, USA

Indiana, USACalgary, Canada