Executive - Quality Assurance Job in Piramal Enterprises Ltd.
Executive - Quality Assurance
- Chennai, Tamil Nadu
- Not Disclosed
- Full-time
Description
Responsible for executing QA related activities assigned by immediate reporting authority / GM-Quality.
Qualification :
Qualifications
1. Strict adherence to GMP, GDP & DI norms and safety rules of the factory.
2. Initiation of change control for QA and review of change control from other functions.
3. Review of QMS documents related to API Services products such as change control, deviation, OOS/OOT, Investigations and followed by tracking and monitoring of CAPA till closure.
4. Review of OOS/OOT investigation from Quality control and other functions.
5. Initiation of deviation for QA and review of deviation from other functions.
6. Review of investigation report arises from 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 of critical deviations are investigated and resolved before release of the API/Intermediate for distribution.
10. Batch release of API/Intermediate for distribution.
11. Review of equipment cleaning SOP, executed cleaning batch records, cleaning validation and line clearance for products.
12. Preparation of QA related SOPs and review of draft SOPs from other functions.
13. Initiation of stability notification for Intermediate/API wherever applicable.
14. Preparation of customer questionnaires and review of agreements.
15. Issuance of quality system documents and forms for operational use.
16. Preparation of Annual Product quality review (APR) and trend analysis on need basis.
17. Preparation and review of process/analytical related validation protocols
and reports.
18. Issuance & receipt of all controlled documents as per document control procedure.
19. Review of equipment/system related qualification document.
20. Responsible for management of Ensur for uploading of QA SOPs and distribution of SOPs & STPs after approval and effect of document.
21. Responsible for audit readiness and support for timely retrieval of document during the audit process.
22. Shop floor vigilance as and when required.
Fresher
2 - 4 Hires
