Deputy General Manager - IPQA

Key Responsibilities

1. Management of IPQA team including resource allocation for various activities.

2. To monitor shop floor IPQA activities including line clearance, sampling activities in manufacturing and packing (General Parenteral, External preparation & Oncology blocks) area.

3. To ensure cleaning, sanitization, sterilization activities, aseptic practices and behaviours at the production floor.

4. To ensure the compliance of the operations in General Parenteral, External preparation, & Oncology blocks in accordance with respective approved SOPs and cGMP requirements.

5. To ensure the equipment used are within the due course of qualification status. 6. Responsible for final release of the batches pertaining to General Parenteral, External preparation & Oncology blocks.

7. Review and approval of the QMS documents pertaining to General Parenteral, External preparation, & Oncology blocks.

8. Participate in risk assessment and investigation of failures like deviation, OOS/OOT, market complaints/ recall etc.

9. Participation in self-inspection programme, internal and external audits.

10. Preparation, review and approval of SOPs.

11. Review and approval of the Qualification / Validation Protocols & Reports, Stability reports, APQRs, MPCR, calibration, preventive maintenance reports, trend reports and other cGMP records.

12. Conducting technical training programmes on cGMP, on job training etc.

13. To perform various SAP/LIMS transactions.

14. Co-ordination with RA and third parties.

15. To assist, if any discrepancy / deviation found during production activities.

16. Coordinating activity related to regulatory and customer audit compliance