岗位职责：

1. 学习国家药品法律、法规，以指导质量管理工作；

Learn national drug law and regulations, in order to guide the quality management work.

2. 分析现场日常巡查，确保现场执行和SOP、法规要求的一致性；

Responsible for perform on-site daily inspection, and make sure the compliance between the operation on-site and SOP and regulation.

3. 审核与分析相关的文件，包括质量标准、分析方法；

Review the documents related to analysis, including quality standards and analysis methods.

4. 审核分析终产品的检验记录和分析证书；

Review the records and certificate of analysis of the final products;

5. 审核分析相关的电子数据；

Review the electronic data related to analysis；

6. 审核对照品标定方案和对照品分析证书；

Review the reference standard qualification protocol and certificate of analysis;

7. 审核分析方法验证方案、验证报告；

Review the protocols and reports of analytical method validation;

8. 审核产品稳定性方案和报告；

Review the protocols and reports of stability;

9. 合同实验室的管理；

Responsible for the management of QC contract laboratory;

10. 仪器验证文件编号的下发；

Issue the file number of analytical instrument validation.

11. 审核分析仪器确认、验证方案和报告；

Review the protocols and reports of analytical instrument validation and verification;

12. 审核分析仪器用户需求标准（URS）；

Review the User Requirement Specification of analytical instrument;

13. 协助分析系统相关的变更、偏差、CAPA、OOS的管理；

Assist in the completion of the management of change control、 deviation、CAPA and OOS which are related to QC.

14. 下发、回收分析相关的质量标准、验证方案等；

Distribute the specification, validation protocols related to analysis;

15. 完成本部门领导安排的其他工作。

Complete the work assigned by the leaders.

任职资格：

1. 具有化学、制药及相关专业本科及以上学历，优秀人员可适当放宽条件，包括工作经验。

Bachelor degree or above in chemistry or pharmaceutical or related majors excellent personnel requirement can be appropriately related to include work experience.

2. 有3年以上相关工作经验。

Have 3 years or above work experience.

3. 熟悉原料药相关GMP法规。

Familiar with GMP and relevant regulations about API.

4. 具有很强的团队协作意识和沟通技巧。

Have strong sense of teamwork and communication skills.

5. 具有较强的任务执行能力。

Have strong ability of task execution.