Vijay Narasimhan

Background

About Vijay Narasimhan

An experienced Quality Control Operations and Compliance professional with an extensive research experience and strong background in managing QC operations team and executing a wide range of quality control operation and compliance activities. I have a proven track record of collaborating effectively with various cross-functional teams and exceptionally experienced in managing quality events such as Change Control, Quality Events, Deviations, CAPA, and MOC. Extensive experience with Master Control and Veeva for QMS management. Proficient in creating User Requirement Specifications (URS), Equipment Qualification/Validation, and the development of SOPs to optimize QC laboratory operations. My expertise lies in building and nurturing external vendor relationships, ensuring the timely release of cell therapies, and maintaining a stringent adherence to GMP standards. Extensive experience with equipment related data integrity, with hands-on experience in equipment Data Integrity Risk Assessment and Control Assessment. Proficient in sample and material management, including coordinating with external vendors and logistics partners to streamline processes and well-versed with LIMS, TWD-DMS, D365, Quartzy, Qulaer for efficient lab management. An established researcher with a Ph.D. in Biochemistry and Biophysics and more than a decade of industrial and academic experience with extensive experience in molecular biology and protein expression and purification. My academic background includes extensive work on GPCR expression and purification, modeling Zebrafish for various genetic diseases and disorders. I excel in the handling, maintenance, and modeling of Zebrafish and generating drug screening models in cell lines and Zebrafish embryos. Have extensive experience in screening drug candidates and small molecules on cell lines and Zebrafish models to identify novel drug candidates.