- Review & approval of Quality system related documents like change controls, deviations, market complaint, OOS, IPOOS, OOT & CAPA.

- To monitor and coordinate IPQA activities in manufacturing and packing area.

- Review and approval of master documents like SOPs, protocol and reports, specifications, standard test procedures, batch manufacturing record, batch packing records OPML etc.

- Review and approval of quality risk management.

- Review and approval of APQR and implementation of recommendations from APQR.

- Review and approval of hold time study documents, validation and qualification documents.

- Approval of various documents in SAP system.

- Performing self-inspection, audit of contract testing laboratory/third party vendor audit/vendor audit and review of related documentation.

- Investigation of quality matrices like deviations, out of specification results, out of trend results, market complaints, batch failures etc.

- Handling the regulatory audits/Inspections and ensuring the responses & compliances.

Work Experience

12-15 years

Education

Graduation in Pharmacy

Competencies

📌 Senior Manager (India)
🏢 LUPIN
📍 India