Currently having An Urgent Requirement for "General Manager- QA/RA" for one of the Pharma Company based in Hyderabad/ Secundrabad.

Desired profile of the candidate:

Candidate should be a B.Pharm/M.Pharm with experience of 15 to 20 yrs in Corporate QA & RA Department in a Formulation unit from reputed organization.

Job Overview:

1. Formulate Quality policies, procedures to ensure compliance for cGMP,cGLP in mfg, testing, release and distribution practices across the company

2. Review of Quality Performance of the plant periodically and update the senior management by periodic Quality review meetings

3. Post market stability of products and quality surveillance.

4. Review and approve OOS,change controls and monitor the system.

5. Review and approve protocols for equipment qualification, process qualification, stability etc for finished products

6. Qualification and evaluation of vendors.

7. Monitor validation schedules and timelines in coordination with allied departments and ensure validation compliance.

8. Approval authority of outside labs and customers.

9. Analytical method development, QC support for timely delivery

10. Lead investigations for OOS, market complaints.

11. Ensure analytical development operations are in line with regulatory expectations.

12. Training of people for cGMP,cGLP, cGRP at plant and PARC

13. Lead interactions and knowledge improvement programs for QA,QC, RA and PARC.

14. Reduce incidence of operation failures by continuous improvement in processes and knowledge.

15. Review of internal audits and quality issues along with allied departments

16. Regulatory compliance to filings at the plant

17. Coordinate with marketing, FRnD, ARnD, Production and allied departments for finalize the strategy for filings and product lists.

18. Coordinate with external customers and regulatory agencies for regulatory submissions and approvals thereof.

19. Filings on time and reduce lead time for response to queries.

20. Mfg lic, COPPs, FSC, etc procurement in time.

21. Finalizing budgets for QA,QC,RA.

22. Regulatory feedback sharing and updation of knowledge with all allied departments

23. Upgrade the quality and documentation systems in the plant and Analytical R&D and Formulation R&D at R&D for regulatory compliance and audits my International and domestic regulatory bodies.

Plus any other work assigned by the Managing Director.

If you are interested then please share your profile or can call me on +919725000311.

Jignesh. Shetty

Sr. Resource Specialist.

ForretIndia Pvt Ltd.

Ahmedabad.

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