Assistant Manager - Formulation Technology Transfer

Job description

**ROLES & RESPONSIBILITIES:** - Receive instructions from the Manager/Assistant General Manager and ensure timely execution of assigned activities. - Ensure compliance with GMP requirements by following proper gowning and de-gowning procedures and ensuring adherence by all personnel in the production area. - Keep superiors informed of all departmental developments and ensure compliance with SOPs, company policies, rules, and regulatory requirements. - Provide guidance and direction to subordinates for the planning and scheduling of Technology Transfer activities. - Prepare and maintain technical packages and documentation related to Technology Transfer in accordance with GMP and regulatory requirements. - Review documentation related to New Product introductions and regularization of existing products, including preparation and review of QFR, BMR, ISP, PPQP, PPQR, ESR (Exhibit, Engineering & Site Shift Exhibits), MFC, and other relevant documents. - Review Gap Analysis reports received from the Technology. Sending and Receiving Teams and ensure appropriate actions are taken. - Review Knowledge Sharing Presentations for site-shift products, including product history, critical process parameters (CPPs), critical quality attributes (CQAs), granulometry trend data, equipment equivalency evaluations, market complaint details, and stability trend analysis. - Coordinate with QA, QC, Production, SCM, and PPC departments to discuss and manage activities related to site-shift products at both sending and receiving locations. - Verify in-process checks as specified in the Batch Manufacturing Record (BMR) and ensure accurate online recording of data. - Maintain quality systems throughout Technology Transfer activities to ensure compliance with regulatory requirements and successful audit outcomes. - Coordinate with the Technology Review Committee (TRC) for New Product Development activities, including technology receipt, planning, and final execution. - Coordinate with technology sending and receiving teams to ensure the availability of required resources and documentation for product transfer activities and evaluate equipment and instrumentation requirements for procurement at receiving sites. - Execute and monitor Engineering Batches, Optimization Batches, Exhibit Batches, and Validation Batches at site-shift locations. - Ensure thorough understanding and compliance with all written procedures, manufacturing instructions, batch records, and quality documents before initiating production activities. - Review Engineering Batch Summary Reports, Exhibit Batch Summary Reports, Validation Summary Reports, and PPQRs in coordination with the sending and receiving teams. - Continuously improve existing formulations, manufacturing processes, and machinery in coordination with Production and Formulation Development departments. - Identify and implement improvement opportunities in: 1. Process efficiency 2. Productivity enhancement and cost reduction 3. Manufacturing automation, including product operation recipes and related systems - Ensure adherence to Quality, Health, Safety & Environment (QHSE) Policies and Energy Policies and Procedures. - Motivate and guide subordinates to promote teamwork and maintain a positive work environment in coordination with the Human Resources Department. - Conduct training programs for departmental employees on process requirements, safety practices, and QHSE policies and procedures. - Ensure completion of all required SOP trainings on a periodic basis for self and departmental personnel. - Coordinate activities related to CMO manufacturing operations, including site visits, document transfer, monitoring, and other associated activities. - Perform SAP-related activities as required to support departmental operations. **Department:** Formulation Technology Transfer **Designation:** Assistant Manager **Location:** Dahej **Qualification:** B. Pharm./M. Pharm. **Total Experience:** 9 to 18 Years+ **Preferred Candidate Profile:** Candidates should have experience in Plant Technology Transfer specifically in OSD formulation. Interested candidates share your updated CV on **akshitsharma@torrentpharma.com** .