Manager - Corporate Quality Assurance - Pharmaceutical Formulation

Corporate Quality Assurance Manager in pharmaceuticals formulation, Age Below 45 years

1. Manage day to day activities of QA-HO.

2. Review and Approval of master documents, BMR, BPR, RMS, PMS, FPS and MOA.

3. Review and Approval of change controls, deviations, SOPs, destruction certificates.

4. Monitoring of all the third party and loan license products.

5. Liaise with production planning, purchase, export, logistic, distribution, and registration department to achieve the production/ dossier submission targets.

6. Plan and perform vendor/ third party/ loan license/ warehouse audits

7. Provide regulatory support and guidance for application of license.

8. Handling of complaints, investigations and initiation of CAPA.

9. Manage Vendor Development process for raw materials

10. Review of Process Validation/ Stability Protocols.

11. Loan License and Third Party Product Development.

12. Be a part of New Product Development team and give suggestions/ inputs for the development of products.

13. Taking overview of our own factories, third party and loan license locations.

14. Monitoring of Batch Release process for domestic as well as all export products.

15. Review of stability data.

16. Provide support to analytical team for analysis of raw materials and finished products.

17. Prepare, submit and monthly review meetings

18. Handling of the consumer queries

19. Maintenance of the documents like price list, product list etc.

20. Review and approval of First Lot to Sales products

21. Monitoring of ERP entries for raw and packaging materials and finished products.

22. Trainings to all the concerned departments on the systems/ SOPs etc.

23. Adequate knowledge on current GMP/ GLP/ FSSAI guidelines

24. Handling of registration queries