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2.0 - 5.0 years
3 - 4 Lacs
Baska
Work from Office
Execution of IQ, OQ and PQ for new equipment, facility & utility system, report preparation and maintenance of record. Execution of Periodic performance verification activities for equipments, facility, utilities and its report preparation. Review Initial qualification master document like URS, GxP assessment, DQ, FAT, SAT, IQ, OQ, PQ and PPV of EFU system and all executed report. Handling of departmental QMS activity through track wise software, discrepancy / deficiency activity compliance of observation, summary preparation for regulatory submission. Qualification and Periodic performance verification activity execution, compilation, review of reports [Filter integrity test (PAO), air velocity, non-viable particle count, air flow pattern as per define schedule, review of calibration certificate for measuring devices]. Ensure and updation of periodic performance verification, calibration, Bulk SIP and smoke study schedule as per available data. Review of all AHU PAO test and NVPC report form for periodic verification, Filter Replacement intimation form, Equipment/instrument inward & Deletion intimation slip & all equipments print reports during qualification. Preparation of master document for periodic performance verification of EFU system Preparation & review of SOPs through EDMS Software Execution of FAT and SAT of equipment, facility and utilities as per requirement. Equipment Periodic performance verification schedule preparation, review, updation and provide data required for monthly report preparation. QE related Instrument calibration schedule preparation (Ellab wireless system, Ellab wired system, Rotronic data loggers certificate review and updation as per available data
Posted 4 days ago
2.0 - 6.0 years
2 - 7 Lacs
Baska
Work from Office
For Production : Exposure pertaining to groninger vial filling , groninger bottle filling, fedegari autoclave, NKP vial filling machine, lyophilizer , spray dryer , aseptic process, complex manufacturing, exposure to CIP/SIP, skid manufacturing, pre filling syringe , QMS is required. Experience required is 2-6 yrs. For Engineering : Should to preventive/ breakdowns maintenance of sterile manufacturing plant, maintenance of autoclave, filling machine - vial, bottle, ampoule, ophthalmic, lyophilizer, freeze dryer machine , BFS machine is required. Experience required is 2- 6 yrs. Job Location : Sun Pharmaceutical Medicare Limited : Nr. Hotel Sarvottam, Survey NO 22 & 24 , Village : Ujeti , Post :Baska , Tal: Halol : 389350 Dist. Panchmahal, Gujarat, INDIA. Mb No : 02676 610 603 / 628
Posted 1 month ago
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