Experience

Dt&CRO

• South Korea
• Biotechnology Research
• 1 - 100 Employee

• QA Manager

  • Dec 2021 - Present

  Quality Assurance – QA Auditor - SOP management; Assure the quality comply with GCP - Support MFDS Inspection - Perform internal Audits; on-site audit, in-house audit - Training Management - CAPA Management Quality Assurance – QA Auditor - SOP management; Assure the quality comply with GCP - Support MFDS Inspection - Perform internal Audits; on-site audit, in-house audit - Training Management - CAPA Management



University of California, Los Angeles

• Information Services
• 1 - 100 Employee

• Laboratory Assistant

  • Aug 2019 - Apr 2020

  * CAPA management * qPCR * Participated in research [Topical application of Porphyromonas gingivalis into the gingival pocket in mice leads to chromic-active infection, periodontitis and systemic inflammation (International Journal of Molecular Medicine 50: 103, 2022, 3rd Author)] * CAPA management * qPCR * Participated in research [Topical application of Porphyromonas gingivalis into the gingival pocket in mice leads to chromic-active infection, periodontitis and systemic inflammation (International Journal of Molecular Medicine 50: 103, 2022, 3rd Author)]



ILDONG Pharmaceutical Company

• South Korea
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• pharmaceutical company QA manager

  • Nov 2008 - Sep 2016

  Quality Assurance Team – Manager • SOP management; Assure the quality comply with GMP regulations. • Deviation Management; Process update to prevent recurrence by managing deviation. • Change Management • Prepare APR(Annual Product Review). • Validation management; Cleaning validation, Process validation. • Assure the manufacturing and quality comply with PICS guidance, KGMP and SOPs. • CAPA Management Quality Assurance Team – Manager • SOP management; Assure the quality comply with GMP regulations. • Deviation Management; Process update to prevent recurrence by managing deviation. • Change Management • Prepare APR(Annual Product Review). • Validation management; Cleaning validation, Process validation. • Assure the manufacturing and quality comply with PICS guidance, KGMP and SOPs. • CAPA Management