Manager- Quality Assurance

Role & responsibilities

Job Description:

1. Responsible for leading the external audit & providing the compliance in timely manners.

2. To ensure GMP Compliance in the plant.

3. To review and approve all departments Standard operating Procedure.

4. To ensure the compliance of all Standard Operating Procedure.

5. Strategic Planning & execution of Quality Management System.

6. To ensure the compliance of the Quality Management system as per the requirement.

7. To review and approve the Site Manager File (SMF), Validation Master Plan(VMP) and Quality manual.

8. Responsible for the approval and release of the Batch.

9. To review & approve specifications, Standard Test Procedure (STP) and General Test Procedure (GTP) of the Quality Control Department.

10. Responsible for Self Inspection or Internal Audit and its compliance.

11. To review and approve all Validation and Qualification Protocols and Reports.

12. To ensure the compliance of Vendor Audits and approval of Contract Laboratory.

13. To impart training on different topics including cGMP and GDP etc.

14. To coordinate during technology transfer of products to the sites.

15. To ensure that products are manufactured as per approved procedure.

16. Responsible for the investigation of the market complaints, Product recall & its compliances.

17. Responsible for review, approval and implementation and verification of Corrective Action and Preventive Action.

19. To provide the compliance reports of audits.

20. To ensure the Qualification and Requalification of the Equipment, Facility and System

21. Responsible for review and approval of Stability Protocol and report.

22 To ensure work discipline in the department.

23. Responsible for quality agreement and its compliance.

Preferred candidate profile

Perks and benefits