Anil Kumar Rapaka

Background

About Anil Kumar Rapaka

Good process knowledge and technical knowledge in Biosimilar products like (Darbepoetin alfa, Rituximab, bevacizumab), Bacterial vaccines (Pneumococcal vaccines) and viral vaccines (Rabies vaccine).Having good experience in handling of deviations/incidents, change controls and CAPA's.Preparation and review of all QMS documents like SOP's, validation protocols, risk assessments, BPR's, lot Summary protocols, Quality risk management etc.Preparation and review of Product quality review report/APQR's/ APR's. trending of in process and final results of process related critical control points and summarization of observations.Good knowledge & experience in handling of media fills, execution and monitoring of process validations and cleaning validations.In shop floor, In process line clearance and monitoring of Drug substance/Drug product manufacturing activities and validation activities to ensure compliance with respect to SOP's, BPR's/process parameters.(Six years experience in Biosimilars, three years in bacterial vaccines, One year in viral vaccines and one year in validations, total 10 years of experience in Biopharma.Good experience in regulatory audits like FDA, EMA, MHRA,INVIMA, WHO, GSK, MEXICO, DCGI, CDSCO,CDL and other regulatory authorities and internal audits.