Varadharaj Vijayakumar
Senior Subject Matter Expert-Aseptic Fill Finish at WuXi Biologics
Varadharaj Vijayakumar is an experienced Pharma/BioPharma professional (16 ~Years), diligent in his core functional area (pharmaceutical technical operations) and committed to the profession. His main area of expertise is aseptic processing & areas of interests are sterility assurance, manufacturing technology, process validation, failure investigations, troubleshooting, continuous improvement, Lyophilization Technology, Isolators with VHP cycle developments and resolution of complex technical/ regulatory/ GMP issues. Additionally, he has experience in facing GMP inspections /audits and responding to the Inspectional observations of various regulatory agencies, such as WHO,USFDA, UK-MHRA, ANVISA, INVIMA, Russia, Romania, Germany, CDSCO etc.
Varad has worked with medium to large, well-respected pharmaceutical/Biological products manufacturing like Franz Ziel GmbH Germany, Pfizer India ,Dr. Reddy’s Laboratories Ltd, Emcure Pharmaceuticals (Oncology Division), Biocon Biologics (India) Ltd and Caplin steriles. He has been involved in many projects from concept design (Green field, Brown field) to successful delivery of commercial product to the continuous improvement phases and also led organization(s) efforts and teams in managing and resolving 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 an active member of professional associations like PDA, TBM, Speak Pharma, R&Y, Conferenzia, Lyophilization World.
In addition to being a pharma-professional, he also publishes technical articles and teaches many young learners from universities. He is also a regular speaker in webinar and a trainer on the topics like qualification and validations for aseptic processing. He is well travelled and has also trained many operational persons on short (Russia, UK, USA, Ireland, India) and long international assignments particularly in the India and Germany.