Vinod Kumar, MSc, PMP, RAC, CLSSBB

GxP Advisor

Vinod is a Quality and Regulatory leader with over 15 years of exposure under GxP operations with various Pharmaceuticals, Biopharmaceutical, Medical Device, 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 optimization, 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, 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.

 

Address

Calgary, Canada