Executive - Quality Assurance

Job Description

1. Handling of change control, Deviations, CAPA, OOS, OOT, Laboratory incidents, Failure investigation, QRM, Field Alert Reports etc.
2. Review and approval of investigation reports of OOS, OOT, Deviations, Laboratory incidents, vendor investigation, failure investigation reports.
3. Review of Annual Product Quality Reviews of Drug Products 
4. Review of analytical document .
5. Handling of stability management.
6. To carry out Self Audits.
7. Handling of Technical Agreements. 
8. Review  of Finished product, Raw material and Packing Material specifications, Test Data sheets, Stability Protocols.
9. Review of artwork & shade cards.
10. Review  of equipment/instrument qualifications etc.
11.  Review of SOPs.
12. Coordinate with RA for fulfilling the requirement of various regulatory submissions

Work Experience

07 to 10 year of experience.  

Education

Competencies