Executive - Quality Assurance Job in Piramal Enterprises Ltd.

Responsible for executing QA related activities assigned by immediate reporting authority / GM-Quality.

1. Strict adherence to GMP, GDP & DInorms and safety rules of the factory.

2. Initiation of change control for QA andreview of change control from other functions.

3. Review of QMSdocuments related to API Services products such as change control, deviation,OOS/OOT, Investigations and followed by tracking and monitoring of CAPA tillclosure.

4. Review of OOS/OOT investigation fromQuality control and other functions.

5. Initiation of deviation for QA and reviewof deviation from other functions.

6. Review of investigation report arisesfrom failure/deviation investigation.

7. Review of Product Development reports(PDR) and R&D use test reports.

8. Review of Master batch manufacturing,packing records and laboratory control records.

9. Review of executed batch manufacturing,packing and laboratory control records of critical process steps and ensuring ofcritical deviations are investigated and resolved before release of theAPI/Intermediate for distribution.

10. Batch release of API/Intermediate fordistribution.

11. Review of equipment cleaning SOP, executed cleaningbatch records, cleaning validation and line clearance for products.

12. Preparation of QA related SOPs and reviewof draft SOPs from other functions.

13. Initiation of stability notification forIntermediate/API wherever applicable.

14. Preparation of customer questionnaires and review ofagreements.

15. Issuance of quality system documents and forms foroperational use.

16. Preparation of Annual Product quality review (APR)and trend analysis on need basis.

17. Preparation and review of process/analytical relatedvalidation protocols

and reports.

18. Issuance & receipt of all controlleddocuments as per document controlprocedure.

19. Review ofequipment/system related qualification document.

20. Responsible for management of Ensur foruploading of QA SOPs and distribution of SOPs & STPs after approval andeffect of document.

21. Responsible for audit readiness and supportfor timely retrieval of document during the audit process.

22. Shop floor vigilance as and when required.