Senior Manager

Lupin Limited; Chhatrapati Sambhajinagar District; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Lupin Limited is seeking a senior QA/IPQA professional in Maharashtra with extensive experience in reviewing and approving quality system documents, deviations, market complaints, and CAPA management. The role requires active monitoring of IPQA activities in manufacturing and packing areas and authority over master documents such as SOPs, protocols, and reports.

The candidate will review risk management plans, APQRs, validation/qualification documents, and SAP records, and will lead internal and

Qualifications

• Review & approve quality system documents such as change controls, deviations, market complaints, OOS, IPOOS, OOT & CAPA.
• Monitor and coordinate IPQA activities in manufacturing and packing areas.
• Review and approve master documents including SOPs, protocols & reports, specifications, STPs, BMR, BPR, OPML, etc.

Responsibilities

• Carry out review and approval of quality risk management.
• Review and approve APQR and implement APQR recommendations.
• Approve hold time studies, validation and qualification documents.
• Approve various SAP system documents.
• Perform self-inspection and audits of contract testing labs/third party vendors and related documentation.
• Investigate quality metrics like deviations, out-of-spec, out-of-trend results, market complaints, batch failures, etc.
• Handle regulatory audits/inspections and ensure compliant responses.

Education

Graduation in Pharmacy

Job description

Job Description

• - 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