1. Ensure production and all production documents are corresponding to Chinese GMP and related regulations.

   确保生产及所有生产文件都遵循中国GMP相关标准。

2. Responsible for drafting and revising process specification, SOP, batch record etc. for launched products;

   负责草拟或修改产品的工艺标准，SOP，批记录等。

3. Production on-site inspection, ensure the validated process being conducted in commercial manufacture.

   负责工厂工艺流程巡查，确保产品工艺流程合规操作。

4. Regular collection and analysis for production data;

   定期收集与分析产品的工艺数据及参数。

5. Assists process senior technician for process validation, cleaning validation and equipment qualification;

   协助资深工艺技术人员进行工艺验证，清洁验证与设备验证。

6. Participation in deviation investigation;  

   参与变更或异常状况调查。

7. Participation in new product introduction

      参与新品引入工作。

[要求]：