We have an opening with pharma company based at Hyderabad

Position DGM - Microbiology(Injectables)

AGM - MICRO :

1. Oversee laboratory activities related to microbiology, environmental monitoring (EM), and laboratory information.

2. Provide oversight on environmental monitoring and microbiology during facility validation activities.

3. Develop the technical, GMP and leadership skills of QC personnel.

4. Ensure laboratory compliance.

5. Ensure quality control policies or procedures are appropriate. Establish and/or revise as necessary.

6. Ensure regulatory and customer inspections readiness; represent area and participate in audits.

7. Ensure compliant and timely testing of raw material, in-process, final product and stability samples.

8. Approve or reject raw materials and in-process, final product based on laboratory results.

9. Ensure laboratory studies and reports are compliant and timely.

10. Evaluate batch records, raw data and laboratory analysis.

11. Approve and authorize specifications, sample instructions, methods, and other quality control procedures, including changes.

12. Approve and monitor contract analysis and laboratories.

13. Ensure quality control department and equipment is maintained and reliable.

14. Ensure necessary equipment qualification and assay validations are complete.

15. Ensure the necessary training within the department is carried out and modified according to need.

16. Monitor and control method performance.

17. Ensure appropriate hygiene practices are followed.

18. Approve and monitor suppliers of materials.

19. Designate and monitor the storage conditions for materials and products.

20. Ensure record retention policies are followed.

21. Monitor compliance with the requirement of Good manufacturing practices.

22. Ensure the inspection, investigation and taking samples is appropriate in order to monitor factors which may affect product quality.

23. Responsible for cost center budget.

24. Review and approval of SOP, STP, GTP, Specifications, protocols, etc.

25. To ensure that organization policies and disciplines are implemented and maintained effectively.

26. To notify the immediate superior in case of OOS, OOT, Deviation, Change control and to fill the required documents. Timely closure of all such notifications with appropriate investigation and CAPA.

27. To update the system as and when required due to any change, revision in regulatory guideline, pharmacopeia, or any additional customer requirement.

28. To update one self with current developments in the functional area.

29. To perform any other work assigned by head of department based on need of organization.

Interested candidates may apply.

Aruna

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