Ankur is an experienced Biotechnology Engineer. He started his career with Analytical Lab and then moved to Downstream Processing, where he worked in Sterile Filtration and Filter Validations. After having worked in the Aseptic Process area, he moved into Validation of Terminally Sterilized products. Trained in the USA, Ankur worked on Sterilization Validation, Terminal Sterilization, D Value Study of Parenteral, Sterilization GAP Analysis, and Sterilization Process Optimization.
After having worked in Validation, Ankur moved into the field of Commissioning and Qualification, wherein he worked as a Project Quality Manager for Fill Finish and Biotech facility for the C&Q of the same. He has also worked for a large Vaccine client for their C&Q project and a Switzerland MNC API C&Q project. Ankur is heading CQV projects across ASIA for OSD, Biotech, API facilities.
Ankur has been involved in GMP Gap Assessment, has been a trainer for GMP as well as Qualification and Validation. He has led the implementation of Risk-Based and Hybrid Approaches for many projects, was briefly involved in the task force for Control Strategy, and has developed a Risk-Based Strategy for Process Support systems.
Ankur has presented at ISPE Conferences and CPHI in India.