Quality Engineer

Sun Pharma

2 - 5 years

3 - 4 Lacs

Baska

Posted:4 days ago| Platform:

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Skills Required

Validation Qualification PQ SAT DQ Quality Engineering AHU EFU system URS PPV calibration GxP OQ EDMS air velocity Report Preparation IQ DTC LMS Smoke Study Utility Systems QMS Periodic performance FAT PAO

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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