Nivedita Kar

I had worked as a competent quality control analyst in the field of bio pharmaceutical with an overall experience of 6years in finished product and stability testing of monoclonal antibodies. I am well versed in all high performance liquid chromatography involved in both purity and impurity testing. While in quality control, supported finished product manufacturing, lab and supply chain for the on time release of the commercial products. Being in quality control: the major activities included: on time batch release by reviewing and compiling the data, COA release for biosimilars and product release in SAP. For timely batch release, it also included the critical activities; to review the trend data, lab incident, out of specification (OOS), out of trend (OOT), deviation/events. To participate in Laboratory investigation of OOS, OOT, Lab incident. Validation, qualification and timely calibration of analytical instruments. While working in quality control also provided support to regulatory for the filing and submission of dossier in different markets. Experience with audits: USFDA, EMA, ANVISA, NPRA, Euthopia, PMDA, DCGI and Canada. Currently working in commercial team for MENA regions, with managing end to end supply operations.