Corporate Quality Manager

Job Responsibilities:

1. Management of new & alternative vendor qualification of all Raw Material & Packing Material.

2. To coordinate with vendor through purchase department for Vendor sample, documents, technical specification ,Technical Agreement & audit.

3. Management of vendor audit as per vendor audit schedule.

4. Evaluation of vendor questioner, vendor check list & audit reports.

5. Updation of Approved Vendor list & distribution with concern stakeholders.

6. Approval of Item code for Raw & Packing material after vendor approval.

7. Management of training & qualification of auditors.

8. Maintenance of vendor documents as per vendor qualification SOP.

9. Evaluation of vendor Quality rating & present to management in Quality Review Meeting.

10. Updation of SOPs & protocols as per new & updated vendor qualification guidelines.

11. Coordination with concern departments for sample analysis, trial and stability study.

12. Coordination with Purchase for updation of Vendor Documents, Audit dates & CAPA.

13. Execution of Risk Assessment of Raw material as per vendor qualification SOP with coordination of other departments.

14. Responsible for RM/PM material rejection analysis and CAPA compliance.

15. Management of Quality Technical Agreement.

Desired Candidate Profile

• 7-12 years of experience in corporate quality assurance or related field (pharmaceutical industry).
• Bachelor's degree in Pharmacy (B.Pharma) or Chemistry (B.Sc), Master's degree preferred.
• Strong knowledge of QMS, ISO 9001:2015, GMP guidelines, FDA regulations, ICHE guidelines, BPR review processes.