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
Beware of fraud agents! do not pay money to get a job
MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.