北京招聘

  

• 负责GMP合规管理工作，确保公司质量方针及质量体系的有效运行；
  Responsible GMP compliance management to ensure that the effective operation of quality policy and quality system of company;

  

• 建立和维护投诉和风险管理程序和相应的记录表格；
  Establish and maintain the procedures and records of complaint and risk management;

• 负责收集整理各部门风险控制情况，协助各部门完成相关风险分析评估报告；
  Responsible for collaborating with each department to collect and sort out the risk control, support departments to finish the completed risk analysis reports;

• 负责协调工厂内的质量风险管控，确保在风险可控的前提下才进行生产相关的活动；
  Responsible for collaborating quality-related risk management at plant to ensure that all manufacturing activities are performed with risk controllable;

• 及时跟进并处理产品投诉，必要时组织协调相关部门进行投诉调查；
  Follow up and handle the product complaint timely and support related departments to organize an investigation if necessary.

        

• 客户投诉关闭及趋势分析，事故风险评估，产品事件汇报等；
  Responsible for the closure and trending analysis of complaints, evaluate the risk of the issues and report to direct supervisor;

• 领导安排的其他工作。

Working task which is arranged by direct supervisor.

工作要求Job Requirement       ？  

本科或以上学历，药学，生物学或化学专业 Bachelor or above degree in Pharmacy, Biology, Chemistry, etc         

熟悉CFDA cGMP, EU cGMP、PIC/S cGMP及FDA cGMP的要求。 Familiar with the regulatory requirement of CFDA cGMP, EU cGMP, PIC/S cGMP and FDA cGMP. ？  

熟悉按照CFDA/FDA cGMP开展自查。 Familiar self-inspection according to CFDA/FDA cGMP ？  

具有较强的处理、分析和解决问题的能力。 ？   Strongly address, investigate and solve ability. ？  

医药行业8年以上生物制药质量管理与监督经验。 ？   No less than 8 years experiences in pharmaceutical quality assurance

英语水平良好，会熟练使用电脑 Good English and computer skill

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。