▷ 회사: 외국계 제약, 바이오 기업

▷ 회사위치: 경기도

▷ Responsibilities
- Lead QC organization with 20~30 associates to ensure product quality control is done according to the standard.
- Review & approval of QC result of Biologics, Semi-finished goods & final products of rapid test, ELISA assay and Urine analysis
- Review and approve Verification & Validation of Incoming Materials
- Review the validation and verification test for process and stability testing
- QC standard material (Panel) management
- Manage of Inspection/Audit and CAPA review and approval
- Transfer test method technology
- Review & approval
- Review and manage of QC Budget

▷ Requirements
- Leadership experience in QC (> 10 years) in bioindustry , medical device or IVD
- Experience in leadership role in organization more than 10 HC
- Exceptional Communication skill in English (in technical writing and conversation)
- Exceptional communication skills and ability to facilitate cross-functional cooperation
- Knowledge on GMP & ISO / Regulatory guidelines
- Compressive knowlege Validation, Verification, Stability, Risk assessment, CAPA and change control process based on ISO 13485:2016
- Global inspection experiences
- Over Bachelor degree in relevant major(Knowledge on diagnosis mechanism (Biological, Immunization)
- Work experience in global company(Preferred)

▷ 상기 job opening에 관심 있으신 분께서는 아래 담당자에게 연락바랍니다.
   담당: 김종민 이사 (jmkim@hijob.co.kr / 070-7126-1950)