A professional who has conducted more than 100 GCP audits

MediRama announced on the 6th that it has appointed Jung-Ah Lee (pictured) as QA Director & GCP Auditor.

Lee previously served as Principal QA Auditor and Quality Director at global pharmaceutical companies and contract research organizations (CROs). She has built more than 17 years of expertise in the quality assurance (QA) field, with extensive experience in Good Clinical Practice (GCP)-based clinical trial audits, Quality Management System (QMS) establishment, Standard Operating Procedure (SOP) development, and regulatory compliance.

She has also conducted more than 100 audits for both global and domestic clinical programs. Her key areas of expertise include Investigator Site Audits, Process Audits, and Vendor Audits. In addition, she has successfully supported regulatory inspections conducted by major authorities, including Korea’s Ministry of Food and Drug Safety (MFDS), Taiwan Food and Drug Administration (TFDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

MediRama stated, “With the appointment of Lee, we plan to further strengthen our services in auditing, QMS consulting, vendor qualification, inspection and external audit readiness, and training.”

Source: The Bio (https://www.thebionews.net)