Section Incharge - QMS

To review/maintain and participate in all QMS documents like, change control, customer complaints, incident, OOS, OOT, CAPA, deviation, investigations, audit report / audit compliance and product returns/recalls etc. To participate and support in all qualification/re-qualification activities like HVAC, Nitrogen, Purified water, Compressed air, QC Instruments, Production equipment etc.

To ensure and review the dispatch activities of finished products. To conduct regular external audits of Vendors and Contract Laboratories and maintain its record. To prepare the agreements with external service providers/laboratories and plan site audit for them. To prepare the report relating to observations of regulatory and customer audits with action plan.

To review and approve BMR’s and BPR’s. Day to day review of data punched for Annual Product Review and prepare APR. Handling of IPQA activties. To conduct internal audits and verify the records. To participate in vendor qualification activities. To review and approve QC specifications and test methods. To maintain, review and conclusion of completed stability of finished product.