Ankur is an experienced Biotechnology Engineer with close to 14 years’ experience . Started career with Analytical Lab and then moved to Downstream Processing where he worked specifically in Sterile Filtration and Filter Validations. After having worked in the Aseptic Process area he moved into Validation of Terminally Sterilized products. Trained in USA and 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 for a Switzerland MNC API C&Q project.
Ankur has been involved in GMP Gap Assessment and have been a trainer for GMP as well as Qualification and Validation. Led implementation of Risk Based and Hybrid Approach for Commissioning and Qualification for many projects. Was also briefly involved in the Control Strategy and have developed Risk Based Strategy for Process Support systems.