13 Aug
|
Torrent Pharmaceuticals
|
Dahej
13 Aug
Torrent Pharmaceuticals
Dahej
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 Recent 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 s
📌 Assistant Manager (Dahej)
🏢 Torrent Pharmaceuticals
📍 Dahej