DGM - Production - Pharma

1. Responsible for manufacturing and Packaging activities of LYO & DPI Injectable Sections.

2. To approve the instructions relating to manufacturing and packaging operations (SOPs, Batch processing records) and ensure their strict implementation.

3. To evaluate proposed changes in product, process, packing or equipment and ensure that appropriate validations are done.

4. Internal & external quality audits and ensure compliance on non-conformances reported.

5. To ensure that the production operations are carried out as per cGMP regulations.

6. To ensure that required initial and continuing training of the department personnel are carried out.

7. To ensure that requisite documentation like monthly stock statements, production reports are made.

8. To ensure that calibrations and preventive maintenance are done at regular intervals.

9. To coordinate with PPIC regarding manufacturing and packaging schedules.

10. To overview the activities related to Raw material and finished goods stores.

11. To participate in vendor qualification process and also in vendor audits, wherever necessary.

12. To ensure that plant hygiene including cleaning and sanitation are performed and maintained.

13. To complete the responsibilities assigned by operations head or his designee.

14. Shall be responsible to participate in Quality Risk Management exercises.

15. Review the cleaning Process record templates.

16. Review the cleaning validation protocol / Reports.

17. Review the sampling results.