工作内容Job Description

1. 收集各部门年验证项目，协助上级起草公司年验证总计划及验证年度总结；

Collecting annual validation item of each department，assist superior to drafting annual validation plan and annual validation Summary.

2. 监督各部门验证计划执行情况；

Supervise the validation plan implementation of each departments.

3. 参与各部门验证方案和验证报告的审核, 配合其他部门进行其他验证工作；

Participate in reviewing of the validation protocol and report, coordinate other departments

with their verification.

4. 监督检查在验证实施中的偏差及整改措施；

Supervise and check the implementation of the deviation and corrective measures in validation.

5. 参与产品工艺验证的实施，监督关键工艺参数的实用性及偏差和整改措施，追溯验证最终产品质量的符合性；

Participate in implementation of product process validation, supervise the practicality of

critical process parameters, the deviation and corrective measures, track the conformity of the final product quality.

6. 起草、修订与验证有关的报告及规程；

Draft and revise the reports and procedures related to verification.

7. 起草、审核、修订、复审职责相关的文件；

Prepare, review, revise, recheck the document related to the responsibility.

8. 起草审核本部门职责相关的报告；

Prepare and review the report related to the responsibility.

9. 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Qualification

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. The requirements of

excellent personnel can be appropriately relaxed, including 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.