Executive - QA (QMS- Injectable Oncology Plant)

Department

Quality Assurance

Educational Qualification

B. Pharmacy / M. Pharmacy / MSc

Designation

Executive – QA (QMS- Injectables Oncology Plant)

Job Summary

Quality Management System

Reporting To (Designation)

Manager / Sr. Manager- Quality Assurance

Job Responsibilities :

1. Responsible for handling and review of Quality Management system including Change controls, Deviations, Non Conformances, investigation and Corrective and Preventive Action.

2. Preparation of CAPA, tracking of CAPA response and implementation and CAPA closure.

3. Handling of product complaints and ensuring the investigations and closure.

4. Handling of Out of Specification (OOS), investigation and closer of OOS.

5. Handling of Out of Trends (OOT), investigation and closer of OOT.

6. Tracking and Handling of Quality Risk Management.

7. Review of Standard Operating Procedure and its compliance.

8. To impart training to departmental personnel on own departmental SOPs and cross functional SOPs.

9. Updation of Site Master File.

10. Preparation of Monthly and Quarterly Review for Management Review.

11. To perform any other works as and when assigned by Head of department.

Skills Required

Quality Management System, deviations