Quality Assurance Executive

0 years

1 - 0 Lacs

Posted:1 day ago| Platform: SimplyHired logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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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