Quality Assurance- Product release, APQR, Complaints, Recall, Deviation, CAPA, Change Control, Batch record, Vendor Audit, CMC, CTD, CMO, PIP, IP Management, Document Control, GxP Training

Quality Assurance for Drug Substance and Drug Product: SOPs, Deviations, CAPAs, Change Control, KPI, Complaints, Recall, PQR, Inspection readiness, Batch records, Visual Inspection, Artwork, Batch release, GMP Audits, Internal Audits

- QA for drug product- QA for drug substance- Batch Release- Raw material release- Qualification & Validation (Process validation, Cleaning validation, Equipment/utility validation, shipping validation, etc.)- Regulatory agency inspection - Deviation, CAPA- Change control - Batch record - F&F CMO- CMO QA team leader- Manufacturing walk-through, QA oversight- Aseptic operation- Labeling & packaging- Visual inspection- Audits: 해외 CMO 업체 감사(미국, 독일, 터키, 벨기에, 포루투칼, 일본 등 20여개 CMO 업체), For-cause Audit (미국/싱가폴 West, 독일 Nuvisan)- 미국 FDA Warning Letter 대응: Product Impact Assessment, Risk Assessment, Historical Deviation Review, White Paper 작성(No vacuum, Particle), Historical Media fill review

밸리데이션QA: 셀트리온 1공장 밸리데이션 업무엔지니어링QA: 셀트리온 2공장 건설 엔지니어링 QA 업무APIQA: Deviation, CAPA, Change control, Batch records, Validation, Calibration, Cleaning validationDPQA 매니져: Deviation, CAPA, Change control, Batch records, Fill & Finish, Aseptic Operation, Media fill, QA walk-through, Product to product change-over release, Regulatory Inspection