글로벌cro QA Lead(8년 이상)
페이지 정보
등록자 :
강대필상무
등록일 : 21-02-19 09:43
기본정보
| 글로벌cro QA Lead(8년 이상) | |||
| 임상 | 과장~부장 | ||
| 무관 | 무관 | ||
| 서류전형 -> 1차면접 -> 2차면접 | |||
| 2021-02-19 | 채용시 | ||
상세정보
본문[담당업무]
1.Plan and Conduct CAS Internal Audit 2.Conduct Contract Audit / Project Audit 3.Conduct Internal System Audit / Vendor Audit 4.Consultation and support the SOP and process improvement to Quality & Compliance Management Department of HOLDINGS Co., Ltd. Based on audit results. [자격] -Minimum bachelor degree (major in medical /pharmaceutical/veterinary sciences, nursing or other science-related background) from a recognized institution, and/or equivalent combination of training and experience -Certificates in Basic GCP, Advanced GCP courses, and GCP Auditor, and other GXP, preferred -Minimum 8 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 3 years direct experience in QA/QC with good performance -Experience in hosting, coordinating, and/or conducting audits and regulatory inspection with clinical trial relevance -Has experience in supervisory/leading role -Comprehensive understanding of quality management systems initiatives and standards, including experience in writing policies and procedures -Good knowledge of medical terminology and clinical/medical practices and a working knowledge of current GXP regulations and guidelines -Good understanding of cross-functional processes, clinical trial processes and regulatory environment -Effective written and verbal communication skills, preferably with good command of English |