工作内容Job Description：

1. 审核公司质量管理文件和质量管理体系与新颁布的国家法规的符合性；

Review the compliance of the quality management document with the new published laws and regulations.

2. 协助进行国外药政法规、行业指南的查询，及时了解国外药品管理的新动向，对本公司质量管理提出新的要求及纠正预防措施；

To assist leader for searching the external regulatory laws and regulations, industry guidelines, and understanding the new trend of the external drug management in time, proposing new requirement and CAPA to quality management of the company.

3. 管理组内的工作并解决工作中的问题；

Responsible for managing the work assigned to the and solving work problems.

4. 负责与相关部门团队协调沟通，将工作任务进行合理分配；

Responsible for communicating with relevant department and team, assign work reasonably.

5. 负责审计中职责相关缺陷整改工作；

Responsible for the response to the corrective action of the observations relevant to responsibility during the audit.

6. 负责变更、偏差、CAPA、投诉、退货、召回及质量协议的管理；

Management of Change Control, Deviation, CAPA, Complaint, Return, Recall and Quality Agreement management.

7. 维护、审核GMP 相关部门的组织机构图，关键岗位人员职责；

Maintenance and review the GMP organization chart and the responsibility of the key position staffs.

8. 组织进行年度计划、质量回顾等总结性工作；

Organize annual plan, quality review and other summary work.

9. 负责物料相关工作的管理；

Responsible for material management related work.

10. 协助部门领导负责外部质量活动沟通工作；

Assist department leader to communicate with external quality activities

11. 负责供应商管理工作；

Responsible for supplier management.

12. 协助上级起草审核本部门职责相关工作；

Prepare and review the work related to the responsibility；

13. 组织进行内部审计；

Organize that internal audits are taken regularly.

14. 协助部门领导进行日常事务管理；

Assist department leaders in daily affairs management.

15. 监督质量管理系统的执行是否符合要求；

Supervise the implementation of the quality management system to meet the requirements.

16. 完成本部门领导安排的其他工作。

Complete the work assigned by supervisor.

任职资格Qualification

1. 具有化学、制药及相关专业本科学历。

Bachelor degree in chemistry or pharmaceutical or related majors.

2. 有3年以上相关工作经验。

Have 3 years or above work experience.

3. 熟悉ICH Q7,GMP 等相关法规。

Familiar with ICH Q7, GMP and relevant regulations.

4. 有较强的工作条理性、计划性。

Have a strong work ethic and planning.

5. 具有一定的语言基础（中英文互译）。

Have a certain language foundation (Chinese-English translation).

6. 具有很强的团队协作意识和沟通技巧。

Have strong sense of teamwork and communication skills.

7. 具有较强的任务执行能力。

Have strong ability of task execution.