SUBRAT K.
Senior Quality Assurance Manager
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Subrat K. is a seasoned Quality Assurance professional with over 22 years of experience in the pharmaceutical industry, specializing in Corporate Quality Assurance and multi-site operations. His expertise in directing Quality Management Systems and navigating complex regulatory environments has been proven through successful audits by USFDA, EU GMP, and WHO across various global regions, including India, Japan, and Tanzania. At Glenmark Pharmaceuticals, he excels as an Assistant Manager of Quality Assurance, leading strategic audits and compliance verification at contract manufacturing locations in India. Subrat actively participates in regulatory readiness and gap-analysis activities, ensuring alignment with corporate goals. He is adept in handling technical operations such as process and cleaning validation and overseeing technology transfers. His leadership skills are evident in his ability to drive cross-functional collaboration and cultivate high-performing teams. Subrat's role at USV Ltd. further cemented his reputation for excellence in in-process quality assurance and document control.
Experience
Assistant Manager - Quality Assurance (CMS)
Glenmark Pharmaceuticals Ltd. · 2006 — PresentLead audits and compliance verification for Contract Manufacturing locations and manage regulatory readiness through collaboration with upper management. Authorize and review proposals related to Change Control, Deviations, and Incidents while ensuring robust corrective actions are implemented. Conduct root cause investigations for Product Quality Complaints and drive the execution of Technology Transfers, including evaluations of facility suitability and review of validation protocols for various dosage forms. Ensure Schedule M compliance throughout the manufacturing process and oversee quality operations from material receipt to dispatch.Officer - Quality Assurance
USV Ltd. · 2005 — 2006Coordinate in-process Quality Assurance activities and manage document control within operational departments. Undertake process and cleaning validations, perform failure investigations, and implement CAPA solutions. Monitor cGMP compliance while reviewing Batch Processing Records and preparing critical SOPs.
Skills & Expertise
Education
- Bachelor in PharmacyS.I.P.S. (Affiliated to BPUT, Odisha) · 1998 — 2004
- 10+2 Sc.Udala College, CHSE, Odisha · 1998 — Present
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