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Vinay Mishra
MSc – Director
Vinay Mishra is a pharmaceutical quality expert with over 19 years of professional experience in transforming quality systems through innovation, strategic process improvement, and regulatory alignment. As Pharmaceutical Quality Expert at GenZen Pharmaceuticals, he oversees quality system development, compliance, and operational excellence across sterile and non-sterile dosage forms.
Vinay has successfully led quality operations in both greenfield and brownfield projects, including the setup of high-potent sterile and non-sterile manufacturing facilities. His expertise spans Quality Management Systems (QMS), risk management, supplier oversight, contamination control strategies, IPQA, and audit management. Vinay has actively supported or led regulatory inspections by US-FDA, EU-GMP, UK-MHRA, TGA, WHO, Health Canada, MCC, ANVISA, and others. His collaborative leadership ensures robust compliance and efficient technology transfers for global clients and partners.
Education: Master of Science (M.Sc.), Awadhesh Pratap Singh University (APSU), Rewa, Madhya Pradesh, India.