岗位职责:

1）确保药品按照批准的工艺规程生产、贮存，以保证药品质量：To ensure that products are produced and store according to approved master manufacturing documents in order to obtain the required quality

2）审核产品从研发转移到生产的流程，并监控产品规定的流程执行技术转移

Review the process of product transfer from formulation department io production, and

monitor the technology transfer according to the specified process.

3) 审核和批准产品的工艺规程、操作规程等文件：

Review and approval of master manufacturing documents, procedure, etc.

4）确保严格执行与生产操作相关的各种操作规程：

To ensure etrict implementation of the procedures relating to production operations

5）确保批生产记录和批包装记录经过指定人员审核井送交质量管理部门：

To ensure that the batch records of processing and packaging are evaluated and signed by

a designated person before they are sent to the quality management department.

6）确保关键设备经过确认

To ensure the critical equipment has been quallfied.

7) 确保生产相关人员经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容。

To ensure that required initial and continuing training of personnel in production is carried

out and adapted according to need.

8) 监督厂区卫生状况：

The monitoring of manufacturing environment and plant hygiene.

9) 确定和监控物料和产品的贮存条件：

The designation and monitoring of storage conditions for materials and products.

10) 监控影响产品质量的因素。

The monitoring of the factors that may affect product qualily.

任职要求:

1）本科及以上学历

Bachelor degree or above

2）药学相关专业

harmacy, Chemical or related

3）优秀的中英文沟通能力，能够准确地交流高技术信息，并说服不同的受众群体

Excellent communication skills in Chinese and English to accurately exchange highly technical information and persuade diverse audience groups.

4）10年以上制药或医疗器械生产企业工作经验，5年以上生产管理岗位

At least 10 years working experience in a pharmaceutical or medical device manufacturing plant with more than 5 years production management position

5）熟悉cGMP和其他法规要求,熟悉无菌制剂

Familiar with cGMP and other regulation requirements.Familiar with oral sterile product

6）指导和激励下属

Coaching and motivating skills