Urgent Required at S Kant HEALTHCARE Ltd Vapi Gujarat
1) Manager – QA (API)
Qualification – Bsc / Msc / B.Pharm / M.Pharm
Experience– 14+ Yrs
1. To Approve Specification, Standard Test Procedures for Raw material, Packing material and Finished product
2. Preparation, review & approval of site master file (SMF), Validation Master Plan (VMP) and Quality Manual.
3. Preparing the Protocols, review, and execution and approval of Qualification of area, Equipment and Utility.
4. To guide for Preparation & review / approval of Standard Operating Procedure (SOP) related to the Quality System.
5. Preparation, execution and approval of protocol and reports for cleaning Validation activity.
6. Review and approval of Process validation protocol and reports.
7. Supervision of regular self-inspection as per the schedule and verifying the compliance.
8. Conducting training an cGMP, SOP and other subject such as safety, plant hygiene and other subjects.
9. Review and Approval of AHU Qualification data & water qualification data.
10. To guide for Preparation & review / approval of Annual Product Quality Review Reports.
11. Authorizing the issuance of BMR & BPR.
12. Approval of change control proposal, Deviation, Market Complaint, Incident & RM/PM Rejection.
13. Release of Finished Goods for Sale.
14. Handling of Corrective Action and Preventive Action and Its implementation.
15. Approval & monitoring of supplier of material & conducting the audit.
16. Establishment, Implementation & maintenance of Quality system.
17. Ensure compliance of GMP in all six system & co-ordinate with each dept. Head for implementation & monitoring of compliance to SOP’s.
18. Review & approval of the quality documents.
19. Preparing the response & report for various external audits.
20. Monitoring and control of manufacturing environment.
21. Evaluation of In process Controls.
22. To evaluate batch records.
23. To ensure all necessary testing carried out.
24. Retention of Records.
25. Investigation in case of Incident, Market complaint, Product Recall, Out of Specification.
26. To perform and participate regular Self-inspection as per the schedule and verifying the compliance.
27. To perform Audit of contract laboratory.
28. To participate in Management review process performance, Product Quality and QMS for continual improvement