Senior Manager

Lupin; Chhatrapati Sambhajinagar District; Presencial; INR 1.500.000 - 2.100.000; Jornada completa

Descripción de la vacante

Lupin in India seeks a senior QA professional to lead review and approval of quality systems, IPQA activities, and master documents. The role requires strong GMP compliance, regulatory audit experience, and extensive experience in QA processes within manufacturing and packaging.

The candidate should have a B.Pharm degree and 12–15 years of QA exposure. This on-site position offers opportunities to influence quality outcomes across multiple sites in Maharashtra.

Formación

• 12-15 years of experience in QA and quality systems.
• Graduation in Pharmacy (B.Pharm) or equivalent.
• Experience in regulatory audits and GMP is preferred.

Responsabilidades

• 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.

Conocimientos

IPQA coordination

QA documentation

Cross-functional collaboration

Educación

Bachelor of Pharmacy

Herramientas

SAP

Descripción del empleo

• 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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