Varadharaj Vijayakumar

Varadharaj Vijayakumar is an experienced Pharma/BioPharma professional (16 ~Years), diligent in his pharmaceutical technical operations. His area of expertise is aseptic processing & interests are sterility assurance, manufacturing, validation, failure investigations, continuous improvement, Lyophilization, Isolators and resolution of GMP issues. He has experience in GMP inspections and responding to observations of regulatory agencies, such as WHO,USFDA, UK-MHRA, ANVISA, INVIMA, Russia, Romania, Germany, CDSCO. Varad has worked with pharmaceutical/Biological manufacturing like Franz Ziel GmbH Germany, Pfizer India ,Dr. Reddy's Laboratories Ltd, Emcure Pharmaceuticals, Biocon Biologics (India) Ltd and Caplin steriles. He has been involved in projects from concept design to delivery of commercial product to the continuous improvement phases and also led organization(s) efforts in managing Operational and regulatory challenges like regulatory review/production outputs/Validation constraints, Inspectional observations etc. He is a registered pharmacist and postgraduate in Pharmaceutical Sciences and a member of professional associations (PDA, TBM, Speak Pharma, R&Y, Conferenzia, Lyophilization World).