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.

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