工作职责:

1、负责产品工艺及岗位等文件的制定；

Responsible for the formulation of product process and post documents

2、负责纯化车间设备的使用、清洁及维护；

Responsible for the use, cleaning and maintenance of purification related equipment

3、根据公司生产计划，组织各工序有序开展，做好相关部门协调工作，确保按计划达成目标；

According to the company

s production plan, organize the orderly development of each process, do a good job in the coordination of relevant departments to ensure that the target is achieved according to the plan

4、负责按照标准操作规程进行各工序操作，并按照规范填写记录和及时归档；

Responsible for operation of each process according to the standard operating procedures, and filling in the records and filing in time according to the specifications

5、负责纯化工序的相关验证工作；

Responsible for the verification of purification process

6、负责纯化过程偏差、变更的发起、调查和评估；

Responsible for the initiation, investigation and evaluation of deviations and changes in purification process

7、负责纯化生产数据统计分析及电子数据完整性检查；

Responsible for purification data analysis and electronic data integrity inspection

8、负责设备和物料购买、使用和维护；

Responsible for the purchase, use and maintenance of equipment and materials

9、与其他部门的良好沟通协作；

Responsible for good communication and cooperation with other departments

任职资格:

1、专科及以上学历,生物工程、生物学、药学等相关专业；

College degree or above,bioengineering,biology,pharmacy,etc

2、制药企业两年以上纯化研发或生产经验；

More than two years experience in in purification R&D or production

3、熟悉生物制药领域GMP的相关法规要求，能撰写SOP、批记录等GMP相关文件；

Familiar with GMP related regulations in biopharmaceutical field, able to write SOP, batch record and other GMP related documents

4、有较强的抗压能力和团队合作精神，责任心强；

Have strong pressure resistance ability and team spirit, strong sense of responsibility