• To co-ordinate the GMP audits on the site, Audit Checklist execution, follow up for the CAPA, preparation of compliance report and to ensure the effective implementation of CAPA
• To conduct monthly Quality Review Meeting and follow-up the proposed CAPA for its effective implementation.
• To ensure IPQA functions as per batch record and SOP.
• To ensure Quality and cGMP compliance of the products being manufactured and Packed in Main Pharma Block (Tablet/Capsule/Liquid/Parenteral), Penicillin, Cephalosporin, Rifampicin and Herbal block.
• Preparation, review and approval of SOP and ensure proper implementation at shop floor.
• To participate in investigation along with cross functional team to find out root cause of deviation, market complaint, OOS and OOT and implementation of identified CAPA.
• Timely review and approval of change controls, deviations, market complaint, OOS, OOT, CAPA and other QMS documents.
• To review & impact assessment of break down intimation slip (BDIS) and to advise precautions to be taken before, during and after attending BDIS & Closure of BDIS.




• To ensure that batch must be manufactured and checked in compliance with laws in forced in that member state and in accordance with requirement of marketing authorization, registration dossier (ND).
• Review and approval of, MMD I, MMD II, BPR, Qualification & Validation protocol & reports, PQR Validation documents and other Master documents.
• Responsible for timely closing of deviation, change control and CAPA in system.
• To ensure the completion, closing and effectiveness of CAPA raised against non-conformity investigation and different regulatory and customer audit compliance.
• Responsible for timely recall of products following site procedures and to perform mock recall and documented all the activity within timeline as mention in the schedule.
• Responsible for FAR handling and sharing investigation report for registered market complaints.
• To Perform Vendor Audits for Vendor Qualifi

📌 Assistant General Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka