Posted:2 days ago|
Platform:
Work from Office
Full Time
Job Responsibilities:
1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.).
2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc.,
3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc.,
4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement.
5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list.
6. Preparation/Revision of CQA SOPs and making master, effective after completion of training.
7. Review of Master formula and technology transfer documents for API sites.
8. Master product label information update in Traces application as per the site requirement.
9. To provide training of SOPs, cGMP, or other modules as per the requirement.
10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc).
11. Scheduling and participation in self-audits (Sites and corporate functions).
12. Regulatory and customer audit support to sites.
13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs.
14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement.
15. Participation in Quality related meetings.
16. Shall perform any other related work/projects assigned by CQA HOD/Section head.
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