Varadharaj Vijayakumar is an experienced Pharma/BioPharma professional, diligent in his core functional area (pharmaceutical technical operations) and committed to the profession. His main area of expertise is aseptic processing & areas of interest 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 Inspection 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 Wuxi Biologics Germany GmbH, Franz Ziel GmbH Germany, Pfizer India, Dr. Reddy's Laboratories Ltd, Emcure Pharmaceuticals (Oncology Division), Biocon Biologics (India) Ltd and Caplin sterile. He has been involved in many projects from concept design (Greenfield, Brownfield) to successful delivery of commercial products to the continuous improvement phases and also led organization(s) efforts and teams in managing and resolving Operational and regulatory challenges like a 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, and 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 webinars and a trainer on topics like qualification and validations for aseptic processing. He is well-traveled and has also trained many operational persons on short (Russia, UK, USA, Ireland, India) and long international assignments, particularly in India and Germany.