Responsible for Qualifications / Validations which includes Bulk manufacturing, Quality Control, Laundry, Engineering & Warehouse areas compliance, and handling of QMS elements pertinent to entire Bulk manufacturing & Warehouse.
1. Review of SOPs pertinent to Bulk manufacturing, Engineering, Warehouse, Quality Control, and other general areas.
2. Review of URS, DQ, IQ, OQ & PQ protocols pertinent to Bulk manufacturing, Engineering, Warehouse, Quality Control, and other general areas and ensure that further periodic requalifications of Area / Equipment are carried out based on schedules.
3. To ensure the receipt, issue & control of Raw material handling in the site as per applicable in-Sun Pharma control strategies.
4. To ensure GMP compliance with approved procedures/practices as per SOP, escalate the issues w.r.t GMP, report any serious issues observed as per company Quality / Safety policies and procedures.
5. Control and reconciliation of Master / Working Cell Banks and maintenance of relevant documentation.
6. Review of batch Summary protocols and batch release till Drug substance stage.
7. Documentation control of entire plant-related GMP documents.
8. Review of Study protocols like PV/CV/Change over, hold time study and oversight of study execution, data compilation, and review of reports.
9. To ensure completion of Transport Validation activities, Thermal cycle study, and Bio-burden Validation activity for each product as per SOP and Validation Master Plan.
10. To handle Failure investigation of deviations / Out Of Specifications (OOS) / Out Of Trends (OOT) and approve the same by ensuring the appropriate actions are in place.
11. Periodic review of Water & EMP trends.
12. Handling of Deviations, Change Controls & CAPAs pertinent to Bulk Manufacturing areas, Quality Control, Engineering, Warehouse, and Housekeeping areas. Any other associated reports, pertinent to GMP areas.
13. During Internal & External audits, GMP compliance, minimization of observations, and further compliance verification.
14. Continuously upgrade skills of self and subordinates through training to ensure the jobs are performed effectively.
To respond to the marketing & Production Planning queries and provide data to the Regulatory department for regulatory filing and annual amendments. The release checklist is concurrently updated as per regulatory and customer commitments.