医药中间体化学合成车间工艺工程师

主要职责Main Responsibilities:

1.　　 作为生产工艺支持的主要联系人，和研发人员协商,完善和执行车间主批记录。

Point of contact for process support for manufacturing， Consult with process chemist in R&D,  prepare and execute master batch record.

2.    计划，组织和准备设备反应链，反应原料和其他原料药中间体及原料药生产相关因素（例如准备物料平衡图，工艺流程图，风险分析，和工艺研发部/QC协调中控事宜等）

Plan, organize & prepare equipment trains, raw materials and other production factors (e.g. mass balance sheet, PFD, Hazard analysis, coordinate IPC with R&D/QC) for manufacturing of intermediates and drug substances.

3.    在合乎SOP（标准操作规程），HSE（安全环保健康）等规程的条件下，根据工艺操作规程执行工艺。

Execute processes according to batch strategy, Comply with SOP, HSE, and other guidelines.

4.    能和工艺研发部项目组积极沟通反馈，支持工艺研发过程，以保证工艺放大/商业化生产的可行性和可靠性。

Interact with R&D project teams and influence process development in order to guarantee feasibility and reliability of scale-up/commercial production.

5.    一如既往地指导和带领相应的操作团队执行所负责工艺的日常生产工作。

Consistently lead, advice, and guide manufacturing team in the day to day process operations for assigned processes.

6.    能独立负责较为复杂的工艺设备和系统。

Fully responsible for complex equipment and systems independently.

7.    确保生产团队得到相关工艺的培训

Ensure training to manufacturing team on assigned processes.

8.    工艺中出现问题的解决

process troubleshooting.

9.    提供优化工艺的建议，在整个生产过程中时时观察/理解工艺现象，以便更好为可能的工艺改进提供建议。

Provide process improvement suggestions，Interpret process observations in order to identify potential improvements for ongoing process development.

10.  确保生产批记录填写的完整性和正确性，对生产团队提供相应的指导。

Ensures proper and comprehensive batch record. Guide manufacturing team accordingly.

11.  审阅生产批记录（包括偏差/变更评估部分）生产结束后及时完成生产总结报告。Perform internal Batch Record Review incl. deviation/change assessment for QA approval .Complete campaign report in a timely manner.

12.  对车间设备及工艺的持续优化有所贡献。

Contribute to continuous optimization and process improvements initiatives.

13.  积极和不同职能部门进行沟通（如，仓储物流，生产主管等）以确保批次生产的顺利进行。

Interacts with various support functions (e.g. warehouse & logistic, manufacturing officer) in order to guarantee smooth batch execution.

14.  可根据工艺特殊需要担任高级工艺专家的角色。

Can take project specific role as Expert Process.

15.  以及其它GMP,HSE相关的职责/交付

Various responsibilities in accordance to GMP HSE responsibility/deliverable.