Selection of batches of Active Pharmaceutical Ingredients (API) for stability studies.
Sampling, incubation, withdrawal, analysis of stability samples as per schedule.
Stability study monitoring as per requirements of regulatory authorities, vendor requirements and as per ICH guidelines. Submission of Stability testing form to PRC, RA, CFT and other department as per requirement.
Deviation logging, immediate action, impact assessment, investigation, root cause, remedial
action and closing within stipulated time in Trackwise (QMS) software
OOS, OOT, incidences and deviation
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Thanks,
Kamal
Keyskills: OOS OOT incidences and deviation i