General Manager/Senior General Manager/Associate Vice President - Quality Control Head

JD of Quality Control Head(GM/Sr. GM/ AVP) for Hyderabad Location.

Candidate required from South India. We can source from Pan India but he should be South Indian, Preferred only from Oral Solid Dosage (OSD) Industry.

We need a Candidate, Preferable who can speak the local Telugu language , and who have the experience in Execution and Driving ,and People Management skills in larger team of around 425 QC Analyst and Who can handle 800 to 1000 Samples in a month.

JD of Quality Control Head for Unit VII:

1. Responsible for overall Quality control Functions at General Block & OCB of Unit VII.

2. Responsible for approval of raw material, packing material and finished products.

3. To ensure cGLP, cGMP, GDP (ALCOA+) and data integrity compliance in QC laboratory as per written down procedures.

4. Responsible for Audit coordination and Compliance to the audit Observations

5. To impart & ensure adequate training for all QC personnel as per the training planner/schedule and delegate responsibilities.

6. To ensure timely submissions of complete and compliant documents to QA, production and RA.

7. To ensure availability of all required chemicals, columns & other miscellaneous items & their approval for procurement.

8. To ensure timely execution of process validation, cleaning evaluation, stability protocol & samples charging.

9. To approve COA of Quality control & stability samples.

10. To approve Stability Protocols and schedule for stability samples analysis.

11. Ensure the documentation & analysis is carried out as per SOPs/STPs/GTPs and cGLP requirement.

12. To approve specifications, sampling instructions, test methods and Quality Control procedures.

13. To ensure timely investigation are carried out for OOS & OOT.

14. Subject Matter Expert (SME) for Laboratory Investigations.

15. To follow and implement QMS related procedures.

16. Online review & updation of stability results for compilation of data.

17. Review & approval of Exceptions, PNC, CC, CAPA initiation & implementation.

18. Preparation and review of Risk assessments exercises.

19. Handling of internal and external audit as per the requirement and implementation of CAPA.

20. Review and approval of validation protocols and reports.

21. Responsible for approval of DMS documents, miscellaneous protocol and other documents in DMS module. along with exception department head approval.

22. Handling of Process Pad related activities

23. To implement Quality Culture initiatives.

24. To support Quality Culture appraiser for collection of data for assessment.

25. Responsible for review and approval of Training Schedules and Matrix (TNIs).

26. Responsible for Participation