Rajesh Kapoor

Biography

 An experienced Quality operations professional with over 20 years domestic and international experience encompassing Biologics, Drugs and vaccines with respect to CGXP. Familiar with aseptic and non-aseptic operations for small and large companies. Extensive experience with successfully hosting Regulatory Agency inspections by the FDA, MHRA, ANVISA, TGA, Japanese Health Authorities, Canadian Health Authorities and Chinese FDA. Successful in establishing CGMP, CGCP and CGLP Compliance programs, perform GAP assessment and implement long-term corrective actions for a continuous supply of drugs to the market place. Successfully restructured Quality Operations groups to help streamline the Quality (QA/QC) functions for an efficient and cost-effective operations resulting shorter product release times.  

Research Interest

 Pharmaceutical science, Biotechnology