Manager - Quality Assurance Job in Piramal Enterprises Ltd.

Responsible for GMP Compliance and batch release of intermediates and API. Accountable for OOS investigation and approval of analytical method transfer/validation documents of products. Review and approval of facility qualification and co-ordinate failure investigation in Process, calibration and preventive maintenance activity in both generic and service manufacturing facility.

1. Strictadherence to cGMP norms and safety rules of the factory

2. Liaising withexternal manufacturing site for product technology transfer

3. Ensure GMP compliancein generic manufacturing & services blocks.

4. Batch releaseof APIs & Intermediates for market.

5.Approval of Outof Specification investigation report related to Generic and serviceintermediates and API followed by tracking and monitoring of CAPA till closure.

6. Responsible forAudit readiness, handling audits, response & closure

7. Review andapproval of APQR for APIs & Intermediates.

8. Conducting theinternal & external audits as per GMP/ISO9001 standards.

9. To supportmaterial management by vendor evaluation and approvals

10. Co-ordinationwith regulatory affairs department for review and approval of change controldocuments related to process, facility, equipment related to generics productmanufacturing.

11. Review andapproval of qualification document related to process equipment, utility system,facilities and analytical instruments in QC scheduled as per Validation MasterPlan.

12. Investigatingdeviations related to Process, calibration, preventive maintenance followed bytracking and monitoring of CAPA till closure.

13. Review andapproval of analytical method transfer and validation documents related toservice and generics intermediates and APIs.

14. To review and approvalof Standard Operating Procedures, Specxifications and Test methods in ensursystem.

15. Review andapproval of QMS documents related to Services & generic products such as BMRs,ATPs, change control, deviation and followed by tracking and monitoring of CAPAtill closure.

16. Responsible toreview pest control management records of the facility.

17. Responsible forcomputer system validation

18. Attendingcustomer calls and meetings.

19. Data Integritycoordinator (DICO):

a. Preparation ofsite specific SOP in line with Corporate Guideline on DI.

b. Mapping ofcritical processes to identify DI gaps.

c. Compilation ofDIRA. Sharing the completed DIRA&DI assessment to Central DICO.

d. Preparation ofsite specific DI audit schedule.

e. Ensure internalaudits are performed as per DI checklist.

f. Prepare and sharethe DI status update for steering committee review.

g. Develop a DItraining plan for site and ensure its execution

20. Responsible &Information Technology single point of contact for all ITC initiatives.

21. Responsible forany specific task assigned by Head- Quality

22. Conducting cGMPtraining

23. In my absence,decision related to my area of responsibility will be with Head Quality.