北京招聘

注:

1.本岗位为 Temporary position, 合同期限18个月。但所有薪资福利体系同Regular员工一致。

薪资结构：13薪 + 年终奖 + 电话补贴 + 餐补及免费午餐 + 节日费 + 额外商业保险 + 免费班车 + 节假日福利。

2.工作地点在北京市顺义区南彩镇茂华茂华工场1号楼3-4层。

3.英语水平四级及以上；

4.须医药相关专业

Responsibilities:

To perform the role of Quality Assurance Associate, assist QA Manager in maintaining quality management system, including deviation, complaint, change control, self-inspection and supplier assessment. Ensure above activities in compliance with Fisher Clinical Logistics Global Policy, all relevant regulation and industry recommended practice applicable to the storage/distribution and 2nd packaging of clinical trial materials

1. Take the local process owner of Track Wise system, and responsible for system users initial training.

2. Management of Deviation and CAPA system as per FCS procedure. Review and approve the problem report as the QA representative.

3. Monitor product complaint handling, and if necessary product recall.

4. Manage and monitor GxP related change to ensure that can identify the potential risk and take the mitigation action.

5. Management of self-inspection programme. Arrange the implementation of self-inspection and follow up the completion of actions timely.

6. Assist QA Manager in regulatory and client audits. Follow up the implementation of actions for audit finding.

7. Perform pre and post review and approval of production batch records.

8. Responsible for QA release of labelled products in GPMS.

9. Perform QC inspection of incoming goods according to FCS procedure and client specific requirement.

10. Responsible for the release of incoming purchased or client materials and approves material specifications.

11. To check the accuracy of returned goods and supporting documentation.

12. Assist to perform the assessments for new and existing suppliers, and keep the Approved Supplier List updated.

13. Perform ad-hoc duties as requested by line management.

Minimum Qualifications:

1. Education: Junior College or above, in life science, chemical or pharmaceutical/medical related.

2. Knowledge: GxP, preferably the knowledge of clinical trial materials

3. Competency: Good communication skills. Good written English. Problem Solving/Decision Making

Preferred Qualifications:

1. Bachelor degree or above

2. Having QA or QC experience in pharmaceutical companies would be a privileged.

3. Good spoken English

Fisher Clinical Services is a part of Thermo Fisher Scientific, the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $1 billion, we have more than 3500 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings.
辉士尔临床服务是赛默飞世尔科学公司的一部分，该公司是服务科学领域的全球领导者，帮助我们的客户能够让世界更健康、更清洁、更安全。公司年收入为 10 亿美元，我们拥有 3500 多名全球员工，为制药和生物技术公司、医院和临床诊断实验室、大学、研究机构和政府机构等客户以及环境和工业过程控制设置提供服务。