Someshwar M

Dynamic and results-oriented Quality Assurance professional with over 30 years of comprehensive experience in API manufacturing and pharmaceutical quality systems. Proven expertise in establishing, implementing, and maintaining robust Quality Management Systems (QMS) aligned with global regulatory requirements (USFDA, EU GMP, ANVISA, PMDA, WHO-GMP). Adept at leading cross-functional teams, managing audits, and driving continuous improvement initiatives to ensure product quality, compliance, and operational excellence.

DGM – Quality Assurance (API Division) - Matrix Pharmacorp Private Ltd. - Hyderabad

(1996-04)

• Leading QA operations across API manufacturing sites, ensuring strict adherence to cGMP and global regulatory standards.
• Spearheaded multiple successful regulatory inspections (USFDA, EU GMP, PMDA, WHO-GMP) with zero critical observations.
• Implemented electronic QMS, enhancing traceability and compliance monitoring.
• Directed validation lifecycle management including process, cleaning, and analytical validation.
• Coordinated with R&D, production, and QC to ensure seamless technology transfer and batch release compliance.
• Coordinated with Regulatory Affairs and Business Development teams to manage Drug Master File (DMF) submissions and provide timely, compliant responses to customer queries.

Analyst (progressed to Deputy General Manager – Quality Assurance) - Medicorp Technology India Limited - Hyderabad

(1996-04 - 2001)

Joined Medicorp Technology India Limited in April 1996 as an Analyst and progressed through successive roles, ultimately serving as Deputy General Manager – Quality Assurance. Medicorp Technology India Limited was acquired by Matrix Laboratories Limited in 2001. Following this, Matrix Laboratories merged with Mylan Inc. (USA) in 2006. Most recently, in 2024, Mylan's API business units were divested and taken over by Matrix Pharmacorp Private Limited.

Master of Science (M.Sc.) - Pharmaceutical Chemistry - BITS Pilani