Quality Control Manager
15000 人民币~20000 人民币/每月
全职
10年以上
刷新于 3 个月前
276 查看
51 申请
上海
分享
职位职责
Managing the routine operation of the QC team to ensure business delivery at the right quality, cost, and speed
Overseeing several sub-teams such as sample management, reference management, regulatory management, and QC instrument and equipment management
Leading the team to comply with internal requirements in all aspects through end-to-end quality control system oversight
Ensuring all activities in the QC team are performed in compliance with cGMP, data integrity, and EHS requirements
Overseeing the training, evaluation, and management of the staff in the QC lab, including coaching, developing, and supporting them to reach their full potential
Being responsible for GMP audits from regulatory authorities and clients, responding to audit reports, and creating CAPAs
职位要求
Bachelor’s degree or above in pharmacy, chemistry, biochemistry, analytical chemistry, or other related disciplines
Minimum of 7 years of working experience in the biotech or biopharma industry
A good understanding of the overall drug development process
A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset
Comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur.P, ChP pharmacopoeias
Comprehensive knowledge of IND/IMPD, NDA, and ANDA filing
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