I am working as a competent Quality control analyst in field of Bio Pharmaceutical industry with an overall experience of 8.5 years in In process,Finished product,and stability testing of API,Formulation,Monoclonal antibodies. I am well versed in High performance Liquid chromatography involved in both purity and impurity testing. Handle UV,IR,KF auto Titrator, Particle size analyzer, GC instruments. And involved all Raw materials, Packing Materials, inproces sample wet analysis .QC Analytical ,Molecular Biology, Bio Analytical data review, Audit trail for all chromatographic techniques, and Non- chromatographic techniques.Responsible for timely releases of batches with the coordination of all cross functional teams, and ensuring the GLP, GDP, safety activities in working area.Responsible for initiation and closure of Laboratory incidents and Investigations (OOS, OOT and Deviations) within stipulated time-lines as committed.Involving in Specifications and SOPs preparation and Review Responsible for sample management duties, initiation and closure of Change controls within stipulated time-lines as committed.Expert inSAP, Empower & Lab ware LIMS software.Medicines & Healthcare product Regulatory Agency (MHRA)World Health Organization (WHO)United states Food & drug administration (USFDA)Therapeutic Goods Administration (TGA)National Health Surveillance Agency (ANVISA)Local Food & drug administration (FDA)Health CANADA and Other Customer Audits.