GMP Auditor 58

Profile: Participated in audits of various countries including but not limited to: US FDA, Europeans, South American countries, and MFDS (Korea). Participated in internal audit as an auditor, conducted twice a year. Provided source documents for CTDs and reviewed CTDs drafted by regulatory department, specifically regarding to module 3. Participated in site audit conducted by the corporate global audit team (JJRC). Contributed in oversight of overseas manufacturers, including KGMP recertification of MFDS. Based in Seoul Korea and definitely carry out any audit projects in Asia. Fluent in both English and Korean, TOEIC: 985 (Jul 2019), OPIC: Advanced (Oct 2018). Expertise in GMP.