DGM Production SVP

1. To review and implement a Quality Management System for cGMP compliance at the Production (Injectable) plant.

2. To Prepare, Review and Approve BMR, BPR and related documents.

3. Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, Schedule and Track and trace

Serialization & aggregation.

4. Giving the required training also Responsible for Media fill and GMP.

5. Handling of Quality Risk Management (QRM)

6. Responsible for Job allocation of the Production Team

7. To ensure the GMP at all levels in the Injectable plant.

8. To review and approve production documentation for compliance with cGMP requirements.

9. To prepare & review SOPs, Validation Protocols and other related documents at the Production (injectable) plant.

10. To review Change Control, Incidents/Deviations and ensure its closure, within a given timeframe as per respective SOP.

11. Review the signatory for all SOPs, Master Batch Records, Qualification, Validation, documents on analytical and manufacturing equipment, specifications, change control, OOS investigations, and other investigations.

12. To check and review dispensing (Raw material & packing material).

13. Ensure the execution of Process validation and equipment validation.

14. Review batch production Records to ensure the batch has been manufactured and tested according to the laid-down procedure/specification. Record any deviations and investigate.

15. To conduct and monitor calibration, qualification, validation and requalification activity at site.

16. To review the Product License Application and support the Regulatory department in obtaining the product license from the local Regulatory Authority.

17. To review and submit the data/information to Quality Assurance for preparation of

18. DMF/dossiers/applications for registration of the product with the Regulatory Authority of the countries in which the product is intended to be marketed.

19. To ensure implementation of the CAPA initiated because of self-audit, customer, and regulatory audit.

20. To inform Management on quality issues (if any).

21. Ensure compliance with online manufacturing, Filling, Lyophilization, Sealing, Visual Inspection and packing activities.

22. Participation and monitoring of all activities of small volume parenteral (SVP) project.

23. Check and review all documents per training for small-volume parenteral facilities.

24. Responsible for Aseptic behaviour in classified areas.Role & responsibilities

Preferred candidate profile

Perks and benefits