Nirav Vyas

Background

About Nirav Vyas

8+years of experience in the process development and manufacturing of sterile drug product and aseptic dispensing in the industrial work environment in compliance with the Health Canada (HC), Food and Drug Administration (FDA) and Canadian Nuclear Safety Commission (CNSC) regulations. • Led the development of synthesis, purification, formulation, and aseptic filling/packing processes, including process transfer, APSS, scale-up, validation and launch. • Responsibly performed hands-on technical leadership and project management role on programs within the company involved in design, commissioning, and validation of facility and equipments used for the manufacture of sterile pharmaceuticals, including technology transfer of marketed and investigational products. • Prepared and approved written procedures, experimental protocols, process flow diagrams, specifications, technical reports, batch records and qualification protocols. • Executed minor equipment repair and service and worked directly with the service engineers for major repairs to minimize down time. • Hands-on experience on developing systems and metrics to enhance Productivity, Quality and Safety to achieve continuous improvement in the team.