岗位职责:

1.在临床中试和放大项目中提供技术支持，尤其是需要应用创新制造技术的制剂产品。

Provide technical support for clinic trial of pilot and commercial-scale, which requires the application of innovative manufacturing technologies, especially for DP.

2.负责设备性能确认文件以及后续的验证工作

Be responsible for equipment PQ and following PPQ

3.主导工艺流程、方法以及设备的改进

Lead or participate process improvement for process、method and equipment etc.

4.主导或参与产品技术转移。

Lead or participate product technical transfer.

5.负责新产品的引入、技术转移、撰写方案以及批记录、PPQ以及上市后商业化产品的生命周期管理

Be responsible for new product introduction、technology transfer、preparing protocol and BMR、following PPQ and managing product life cycle.

6.技术转移以及后续生产过程中的异常问题处理。

Troubleshooting during technical transfer and subsequent manufacturing.

7.为其他部门人员提供技术培训和研讨会，以促进新制造技术的应用。

Provides technical trainings and seminars to personnel of other departments to promote the application of new manufacturing technologies.

任职要求:

1. 本科以上学历。

Bachelor degree or above

2. 英语口语、书写熟练。

Fluent English in both oral and written

3. 1年或以上制药行业工作经验。

1 year or above working experience in pharmaceutical

4. 熟悉GMP和药品生产管理要求。

Familiar with GMP and drug production management requirements

5. 熟悉口服固体制剂设备工艺/设备。

Familiar with process/equipment of oral solid drug