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
Lead, train & monitor the performance of team members
M.Sc. / Ph.D.in 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