Assistant General Manager

• 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 Qualification as per requirement of RM/PM.
• To perform effective self-inspection as per schedule and ensure timely closing with proper CAPA or justification for the noncompliance found during self-inspection.
• To participate in all internal and external audits and to prepare compliance report against different customer and regulatory audits within given timeline.
• To ensure compliance of Qualification, Re-Qualification, Aseptic Process Simulation (Media fill) Studies as per schedule pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities.
• To ensure compliance with respect to execution of Process Validation, Packing Validation, Transportation Validation, Hold time study, temperature mapping and Cleaning Validation activities pertaining to Dholka site in line with the cGMP requirements of national and international regulatory authorities.
• To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all such international quality standards.
• To appoint the qualified staff for technical function and ensuring their technical and overall development through systematic training processes and reviewing their performance periodically.
• To Perform FAT (Factory Acceptance Test), SAT(Site Acceptance Test).
• Review and approval of Quality Risk management related to equipment, process, utilities etc.
• To prepare and review of Site Master File and Quality Manual.
• To Impart training for IPQA/Shop floor/QMS Team as per schedule and as when required.
• To review and approve specification and STP with respect to current requirement.
• To review and approve quality trends e.g. change control, deviation, market complaint, OOT, OOS trends ad incidence trends for improvement with respect to current requirement.
• Responsible for review and approval of Quality documents viz. change control, deviation and Artwork for Modavar Site.
• To execute the role of QA Head designee.
• To execute additional role assigned by QA Head /Quality Head.