广州招聘

岗位职责：

1、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 effectiveoperation of quality policy and qualitysystem of company;

2、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 riskmanagement;

3、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 sortout the risk control, support departments to finish the completed risk analysisreports;

4、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 plantto ensure that all manufacturing activities are performed with riskcontrollable;

5、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 relateddepartments to organize an investigation if necessary.

6、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;

7、领导安排的其他工作；

Working task which is arranged by direct supervisor.

任职要求：

1、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

2、熟悉CFDA cGMP, EUcGMP、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.

3、熟悉按照CFDA/FDA cGMP开展自查。

Familiar self-inspection according to CFDA/FDA cGMP

4、具有较强的处理、分析和解决问题的能力。

？Stronglyaddress, investigate and solve ability.

5、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 inpharmaceutical quality assurance

6、英语水平良好，会熟练使用电脑

Good English and computer skill

2017年3月，百济神州与广州开发区合作，建设生物药生产基地，直接投资额达22亿人民币。广州生物药生产基地主要生产大分子单克隆抗体类抗癌药。基地采用全球领先的现代生产设备KUBio整体解决方案。

我们的目标是致力于成为一家在癌症研究、药物研发、人才培养和商业准则方面具有全球影响力的公司。
在这里，您的每一分努力都将得到肯定，您的个人价值将在公司的发展中得到充分的体现。