工作内容CONTENT

1.按照已批准的生产规程和批记录进行制剂的生产。

Produce drug product according to approved production procedure and batch production records.

2.及时填写批生产记录及相关附加记录并签名。

Fill in batch production records and related additional record in time and sign.

3. 及时报告生产偏差，协助进行关键偏差的调查，发现问题及时上报生产组长。

Report the production deviations timely, assist the investigation of critical deviations, and report problems to Production Team Leader in time.

4. 确保生产设备设施是清洁合格的，并按照要求进行消毒。

Make sure that production facilities and equipment are cleaning qualified, and disinfect according to the requirements.

5. 协助进行厂房和设备的维护保养，并完成记录。

Assist to complete the maintenance of workshop and equipment, and complete the records.

6. 协助撰写验证方案。

Assist to draft validation protocols.

7. 协助完成新的或经过改造的（必要时）生产设施和设备的确认工作。

Assist to execute the qualification of new or modified (when necessary) facilities and equipment.

8. 完成其他相关工作。

Execute other related tasks.



教育背景和任职资格EDUCATION BACKGROUND AND QUALIFICATION

1. 具有高中以上学历，参加本公司上岗培训并考试合格。

High school education or above, attended the company’s on-the-job training and passed the examination.

2. 熟悉固体制剂生产流程或具有药学理论知识。

Familiar with the production process of solid drug product manufacture or have pharmaceutical theoretical knowledge.

3. 经培训后可以熟练操作车间制剂工艺设备。

Be able to operate skillfully formulation process equipment installed at plant after training.

4. 了解GMP法规。

Understand “Good Manufacturing Practices”.

5. 能吃苦耐劳，服从安排，听从指挥。

Can bear hardships and stand hard work, obey arrangements and follow commands.

6. 具有至少一年以上口服固体制剂生产经验。

At least 1 year OSD production work experience.