Lupin Limited
Designation : Senior Manager
Function : Quality Assurance
Functional Area : QMS, IPQA
Job Role Summary : QMS Documentation and review, investigations, IPQA activities, self inspection
Job Profile :
- 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.
Job Requirements :
- 12 - 15 years' experience in Pharma Quality operations
- Familiar with cGMP requirements and documentation - APQR, Incident Investigations
- Self Inspection, Facing regulatory audits
Work / Job Experience : 12-15 Years
Type of Experience : regulated pharma QA experience
Academic Qualifications :
Graduation in Pharmacy
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