Quality Assurance Executive

3 weeks ago


Thane MH IN BIOSPHERE CLINICAL RESEARCH PVT LTD & Sprutha Impex Pvt Ltd Full time

Job Responsibilities To verify all project specific feasibility documents for DCGI dossier To determine whether the evaluated activities were appropriately conducted and that the data were generated recorded analysed and accurately reported according to protocol standard operating procedures and Good clinical practices GCPs Perform In-house and On-site audits To Review and verify PMF and CSF The systematic and independent examination of all trial related activities and documents Responsible for Quality Assurance for all the IP related Activities Responsible for working within established timelines of investigational product manufacturing labelling release distribution and return destruction and or helping to establish these timelines Responsible to maintain IP storage temperature records on daily basis Prepare maintain or update IMP management File To verify IMP release checklist of respective sites before shipment Responsible for procurement of IP related instruments with calibration records Management of IP Service vendors performance quality timelines and deliverables Qualification Master of Pharmacy Quality Assurance Technique Job Type Full-time Pay 11 823 29 - 40 433 03 per month Work Location In person



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