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Varadharaj VIJAYAKUMAR

Associate Director

Company
TERUMO PHARMACEUTICALS
Position
Associate Director
Biography
Varadharaj Vijayakumar is an accomplished pharmaceutical and biopharmaceutical professional, currently serving as Associate Director – Aseptic Processing at Terumo Pharmaceutical Services GmbH, Germany, and Co-founder of Quantum Bio-Consulting, Germany. Renowned for his technical depth and commitment to excellence in sterile manufacturing, he brings extensive expertise in aseptic processing, sterility assurance, manufacturing technology, validation, lyophilization, isolator systems, VHP cycle development, and the resolution of complex GMP and regulatory challenges. He has significant experience preparing for and managing global GMP inspections and inspection responses, including engagements with WHO, US FDA, UK-MHRA, ANVISA, INVIMA, Russia, Romania, Germany, CDSCO, and other authorities. He has also executed numerous GMP and supplier audits across Europe for sterile and non-sterile products, APIs, and primary packaging materials. Across his career, Varadharaj has contributed to major pharma and biopharma organizations such as WuXi Biologics Germany GmbH, Franz Ziel GmbH, Pfizer, Dr. Reddy’s Laboratories, Emcure (Oncology), Biocon Biologics, and Caplin Steriles. His experience spans concept design (greenfield and brownfield), technology transfer, validation, commercial readiness, and continuous improvement, leading cross-functional teams to address operational, technical, and regulatory challenges. A registered pharmacist with a postgraduate degree in Pharmaceutical Sciences, he is an active member of ISPE, PDA, TBM, and Lyophilization World, and is also a published technical author. As a frequent speaker and trainer, he delivers sessions on qualification, validation, and aseptic processing at major industry forums including PDA, ISPE, BioProcessing Summits, and Innovatrix. He has trained global operational teams during assignments in Russia, the UK, USA, Ireland, Mexico, Thailand, India, and Germany.

Speaker on

Facing FDA Scrutiny with Confidence: Strengthening Control to Prevent Losses and Ensure Sterility

Educational TACKLING PRODUCTION CONTROL CHALLENGES IN PHARMA
05/27/2026 | 17:00 - 17:15 | TPD Room

Tackling production control challenges in pharma

Panel Discussion TACKLING PRODUCTION CONTROL CHALLENGES IN PHARMA
05/27/2026 | 17:15 - 17:30 | TPD Room