Rahul Darekar

Corporate Quality Assurance professional with 16+ years of experience in CMO audits, warehouse/depot/CFA audits, Quality Management Systems (QMS), technology transfers, and third-party manufacturing (TPM/CMO) governance. Skilled in tech pack approvals for new products and driving new product projects at CMOs from NPI (New Product Introduction) through batch release for distribution. Multi-dosage expertise across Solid Oral Dosage Forms, Liquid Orals, External Preparations, Nasal Preparations, MDI/DPI preparations, Ayurveda (AYUSH), FSSAI (Nutraceutical), and Cosmetics.

Proven track record executing risk-based vendor audits, ensuring regulatory compliance, and driving root cause analysis (RCA) and CAPA systems to safeguard product quality.

Assistant Manager – Corporate Quality Assurance (LL/TP) at Alkem Laboratories Ltd. (2016-09 – Present)

• Audit CMOs, central warehouses, depots, and CFAs, preparing schedules and monitoring plans for CMO site oversight
• Lead launch readiness for new products at CMO sites through initial tech pack evaluation, coordinating with manufacturing sites and cross-functional teams
• Review tech packs for new products, including stability study data, process validation data, manufacturing licenses, product permissions, finished product specifications & STPs, analytical method validation, APQR, and RM/PM specifications
• Review and approve Quality Agreements with CMOs
• Manage quality oversight of external manufacturing sites through site visits, training, and risk assessment
• Review deviations and change controls received from CMOs
• Conduct physical verification of new products prior to dispatch
• Prepare SOPs and guidance documents

Executive – Corporate Quality Assurance at Shalina Laboratories Pvt. Ltd. (2011-07 – 2016-08)

• Coordinated and executed tech transfer of new products from R&D to manufacturing sites
• Served on the audit team performing quality audits of contract manufacturing units, third-party manufacturers, and raw material vendors, reviewing compliance and closure actions
• Prepared Annual Product Reviews (APR)
• Prepared, reviewed, and distributed master documents including SOPs and specifications for raw materials, intermediates, and finished products

Research Associate at Sandoz Development Centre (2010-03 – 2010-09)

• Served as a member of the Validation team
• Prepared qualification protocols for process equipment
• Executed equipment qualification protocols
• Prepared SOPs for process equipment

Officer – Validation at Janssen Cilag, Johnson & Johnson Ltd. (2009-06 – 2010-01)

• Qualified process equipment for the Product Development facility
• Conducted pre-approval review of equipment qualification protocols, traceability matrices, and qualification summary reports
• Executed equipment qualification protocols

Master of Pharmacy (M. Pharm) in Quality Assurance Techniques – AISSMS College of Pharmacy, Pune (2008-10)

Bachelor of Pharmacy (B. Pharm) – Dr. D. Y. Patil Institute of Pharmaceutical Science and Research, Pune (2006-04)