北京招聘

1.    Provide guidance and direction regarding Quality Control and Assurance to project teams & CMO;
2.    Lead and implement the batch record review including QC & MFG and support batch release work;
3.    Support and implement the on-site quality control work in CMO per quality agreement and GMP;
4.    Drive, lead and troubleshoot quality investigations /changes at CMOs to ensure that all critical and major quality control issues are thoroughly investigated with appropriate corrective actions;
5.    Support annual product reviews and the development of training programs regarding all aspects of producing quality products;
6.    Monitor performance metrics and drive continuous improvements of CMO QC work;
7.    Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes;
8.    Provide audit/inspection support of CMO, perform audits & support to regulation filling, as needed.
职位要求：
1.    Minimum of 10 years pharmaceutical or biotechnology industry GMP experience in a quality control in manufacturing function
2.    Familiar with lab instruments including HPLC, GC, UV, IPC, ElISA, CZE etc
3.    Familiar with quality control work requirement of sterile product ( injectable solution)
4.    In-depth knowledge of Ch.P (NMPA), other regions including USP, EP and JP is preferred
5.    Familiar with lab operation including instrument, method, documentation, stability work in dteail
6.    In-depth knowledge of GMPs (NMPA), other regions including US, EU, AU and JP is preferred
7.    In-depth knowledge of Quality principles, concepts, industry practices and standards
8.    Excellent verbal, written and interpersonal communication skills
9.    Ability to work independently with business/scientific/technical personnel is preferred
10.    Knowledge of risk management tools a plus

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。