General Manager / DY. G. M. - Q.C.

Vision Management Services
  • Pune
  • 10-20 lakh
  • 10-20 years
  • 08 Apr 2015

  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Overall Quality Control & regulatory compliance. cGMP compliances other requirements
Prepare Specifications, SOPs and Validation protocols.
Change control management & deviations.
Stability of Validation batches as per the guidelines.
Review technical dossier, regulatory filings & DMF matters.
Analytical method development, process Validations, facility qualification, monitoring stability of New API.
Coordinate with QA/RAD/R&D for any correction or revision in such documents as per the
Operation & Calibration of all analytical instruments, installation & qualification of all new
instruments /equipments.
Lead, train & monitor the performance of team members

M.Sc. / Analytical chemistry or org .chem with relevant experience in control function in a reputed Sterile & Non Sterile API/Bulk Drug manufacturing company having USFAD & Other Regulatory Approvals.
Must have hands on experience on all sophisticated instruments

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Vision Management Services