Senior Manager

Lupin; Aurangabad; Vor Ort; INR 1.800.000 - 2.400.000; Vollzeit

Zusammenfassung

Lupin is seeking a senior QA professional based in India (Aurangabad) to oversee review and approval of quality management system documents and ensure GMP compliance across manufacturing and packaging operations.

Candidate should have 12-15 years of experience, a Pharmacy degree, and strong CAPA and regulatory audit exposure to maintain high quality standards in all QA activities.

Qualifikationen

• Experience in reviewing and approving QMS documents and change controls.
• Knowledge of GMP/GLP regulatory audits and regulatory inspections.
• Strong investigation and CAPA implementation experience.

Aufgaben

• Review and approve quality system documents including changes, deviations, market complaints, OOS, IPOOS, OOT and CAPA.
• Coordinate IPQA activities in manufacturing and packing areas and ensure compliance.
• Review and approve master documents such as SOPs, protocols, reports, specifications, and batch records in SAP.
• Lead audits of contract testing laboratories and third-party vendors and drive corrective actions.

Kenntnisse

Quality systems

Documentation review

GxP compliance

Ausbildung

Graduation in Pharmacy

Tools

SAP

Jobbeschreibung

• 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

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