Manager – R&D Quality CMC QA
About this role
Manager – R&D Quality CMC QA
Sun Pharmaceutical Industries Ltd
Position Summary This position shall be responsible for identifying, planning, conducting product pre approval inspection (PAI) at various Sun and Sun CMO sites (Formulation & API) from where product dossiers/DMF’s are submitted to the regulatory agencies in order to assure on time drug product/API approval.
Key responsibilities
- Plan and execute pre approval inspection for various products /API executed at Sun and Sun CMO sites from where dossiers/DMF’s are submitted
- To understand manufacturing, packing process and analytical techniques development and execute audit plan.
- Identify risk factors and ensure quality system is audited to identify risk. are mitigated and closed prior to pre-approval inspection by agency.
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