Production Technician

工作地点：无锡         所属类型：GCS-Formulation         发布时间：2020-07-02

岗位描述：

1. 根据相关SOP及批生产记录的要求完成相关生产操作。根据数据完整性要求填写日志及记录。

Complete the relevant production operations according to the requirements of the relevant SOPs and batch records. Complete logs and batch records according to data integrity requirements.

2. 遵守公司规章制度、标准操作规程以及中国GMP和美国cGMP要求，使产品质量得到有效保证。

Comply with company regulations, SOPs and the requirements of GMP of China and cGMP of US to ensure product quality.

3. 负责生产区的清洁，设备操作及日常维护。

Responsible for the cleaning of production area, equipment operation and maintenance.

4. 协助管理生产线运作和物料安排。

Assist in the management of production line operations and material arrangements.

5. 协助验证工作以及再验证的实施。

Assist in the implementation of validation and re-validation.

6. 协助调查验证或生产过程中产生的偏差。

Assist in the investigation of deviations during the validation or production process.

7. 支持生产程序的建立和维护。

Support the establishment and maintenance of production procedures.

8. 上级指派的其他职责；

Other duties as assigned by superior.

任职资格：

任职条件：

1. 制剂、制药工程、药学或其他相关专业大专及以上学历。

Formulation, Pharmaceutical Engineering, Pharmacy or other relevant education background, college degree or above.

2. 具有二年及以上的GMP口服固体制剂车间生产经验，接受过与口服固体制剂相关的专业知识培训，能够熟练操作维护相关设备。

More than two years of practical experience in GMP oral solid formulation production, have received professional training related to oral solid formulations, proficiency in operating and maintaining related equipment.

3. 了解制剂工艺及设备，熟悉固体制剂生产操作优先。

Familiar with formulation process and equipment, familiar with OSD production operation is preferred。

4. 具有基本的计算机和英语水平。

Basic computer and English skills.

5.具有良好的学习，协调及沟通能力

Fast learning, cooperating, and communicating capability.

6.具有良好的抗压能力及灵活性

Pressure tolerance and flexibility.