Manager - Quality Assurance Job in Piramal Enterprises Ltd.
Manager - Quality Assurance
- Chennai, Tamil Nadu
- Not Disclosed
- Full-time
- Permanent
Description
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.
Qualification :
Qualifications
1. Strict adherence to cGMP norms and safety rules of the factory
2. Liaising with external manufacturing site for product technology transfer
3. Ensure GMP compliance in generic manufacturing & services blocks.
4. Batch release of APIs & Intermediates for market.
5.Approval of Out of Specification investigation report related to Generic and service intermediates and API followed by tracking and monitoring of CAPA till closure.
6. Responsible for Audit readiness, handling audits, response & closure
7. Review and approval of APQR for APIs & Intermediates.
8. Conducting the internal & external audits as per GMP/ISO9001 standards.
9. To support material management by vendor evaluation and approvals
10. Co-ordination with regulatory affairs department for review and approval of change control documents related to process, facility, equipment related to generics product manufacturing.
11. Review and approval of qualification document related to process equipment, utility system, facilities and analytical instruments in QC scheduled as per Validation Master Plan.
12. Investigating deviations related to Process, calibration, preventive maintenance followed by tracking and monitoring of CAPA till closure.
13. Review and approval of analytical method transfer and validation documents related to service and generics intermediates and APIs.
14. To review and approval of Standard Operating Procedures, Specxifications and Test methods in ensur system.
15. Review and approval of QMS documents related to Services & generic products such as BMRs, ATPs, change control, deviation and followed by tracking and monitoring of CAPA till closure.
16. Responsible to review pest control management records of the facility.
17. Responsible for computer system validation
18. Attending customer calls and meetings.
19. Data Integrity coordinator (DICO):
a. Preparation of site specific SOP in line with Corporate Guideline on DI.
b. Mapping of critical processes to identify DI gaps.
c. Compilation of DIRA. Sharing the completed DIRA&DI assessment to Central DICO.
d. Preparation of site specific DI audit schedule.
e. Ensure internal audits are performed as per DI checklist.
f. Prepare and share the DI status update for steering committee review.
g. Develop a DI training plan for site and ensure its execution
20. Responsible & Information Technology single point of contact for all ITC initiatives.
21. Responsible for any specific task assigned by Head- Quality
22. Conducting cGMP training
23. In my absence, decision related to my area of responsibility will be with Head Quality.
Fresher
2 - 4 Hires
