Lydia Prasanna (Manager- QA and RA) has completed M. Sc. In Biochemistry from Osmania University in India. Lydia was the Deputy Manager (QA & RA) for Medical Device and In Vitro Diagnostic Devices at the French group of companies, BioMerieux (RAS Life Sciences), where she has worked for 10 years different roles. Lydia was instrumental to setup the QMS when BioMerieux acquired RAS. She has expertise in maintaining Quality Management systems in line with ISO 13485, ISO 9001 and ISO 15189 pertaining to IVD.
In addition, Lydia has been closely coordinating with the production and R&D team on effective QMS activities as per the SOPs, managing the process of registration, renewals and amendments as per Indian regulatory authorities, preparing the Validation Master Plan and Site Master file, risk-based assessment for all the products manufactured. At EMPE, Lydia takes the lead on QMS, QA/RA and regulatory compliance.