Posted:6 days ago|
Platform:
Work from Office
Full Time
Role & responsibilities Review of Raw Material/Packaging Material /Stability/ Microbiology/ Cleaning Method Validation/ Validation/ Finished Product Analytical data, Certificate of Analysis & related documents. Review and approval of Exhibit Stability Protocols. Preparation and review of validation /pre-validation /commercial/annual addition batch/thermal excursion/additional study stability protocol. Approval of additional testing requests (if required). Review and approval of ln-Vitro/CU and dissolution sheets. Review and approval of Analytical Method Transfer documents. Participation in handling OOS, OOT, Investigation and deviations related to Quality Control. Review and approval of weekly and monthly software verification reports of Empower3. Periodic verification of application software on computer systems, associated with laboratory instruments with system administrator. Review of lab instruments calibration/preventive maintenance data. Review of Stability test results in NOVATEK software. Approval of Certificate of Analysis. Review and submission of analytical data to site regulatory affairs. To provide the response of regulatory affairs and Office of data reliability queries. Review and approval of change control request, specification, standard test procedure and SOP in Documentum Compliance Manager System. Preferred candidate profile Educational Qualification : B.Pharma/M.Pharma with 5 to 7 Yrs of working experience Mandatory USFDA Plant Exposure is required. Note - Sun Pharma does not seek payment of any kind from a prospective candidates for employment with Sun Pharma or authorise any agency or any individual to collect or charge any fees or charges for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be representing Sun Pharma.
Sun Pharma
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