Kinnari Gandhi has done her Bachelor of Pharmacy (B. Pharm) from K.B.I.P.E.R. Gandhinagar, Gujarat, and Master of Pharmacy (M. Pharm) from M.S.University, Baroda, Gujarat.
She has worked with Veeda Clinical Research as an Analyst (Bioanalytical Research) for 2 years and as Senior Auditor (Quality Assurance) for almost 8 years. As an analyst, she developed various molecules using HPLC and LC/MS/MS systems. Apart from these, she was responsible for bioanalytical method validation, its application in project sample analysis for BA/BE studies, operation of Chromatographic software for HPLC and LCMSMS.
As the company’s Senior Auditor (Quality Assurance), she was responsible for QMS setup plus implementation, regulatory audits, vendor audits, sponsor audits, CAPA management, deviation management, trend analysis, GAP assessment, risk management, and report submission. She was also into Software and IT infrastructure validation as well as a certified GCP/GLP trainer.
At CBCC, her role comprises everything from preparing and implementing an effective QMS system for all services offered by CBCC. It includes tasks developing as well as maintaining the GCP/ICH compliant process, scheduling and overseeing audits conducted to ensure all projects are executed as per GCP norms, protocol, quality system regulations, and ISO standards wherever applicable.
