Senior Manager
Role Overview
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
Full Job Posting
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 Competencies
About Lupin Limited
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