工作职责:

1、负责纯化车间环境、卫生管理，主动报告各工序员工健康异常状态；

Responsible for the environmental and health management of preparation workshop, and actively report the abnormal health status of employees in each process

2、负责组织工艺规程、岗位操作规程、设备操作规程、生产批记录及各类文件的编制、修订、下发及监督，确保文件内容与生产一致；

Responsible for organizing the preparation, revision, distribution and supervision of process procedures, post operation procedures, equipment operation procedures, production batch records and various documents to ensure that the contents of documents are consistent with production

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、负责组织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 organizing the operation of each process according to the standard operating procedures, and filling in the records and filing in time according to the specifications

5、协助管理纯化车间的生产工作，解决生产过程中遇到的问题；

Assist to manage the production of purification workshop and solve the problems encountered in the production process

6、负责下属员工的工作进度和绩效管理，向负责人汇报；

Responsible for the subordinate staff

s work progress and performance management of the Department and reporting to the person in charge

8、负责工艺接收、确认、放大及验证工作，完成工艺转移后的临床批生产；

Responsible for process receiving, confirmation, amplification and verification, and completing the clinical batch production after process transfer

9、负责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、本科及以上学历，药学，药物制剂、制药工程等相关专业；

Bachelor degree or above, major in bioengineering, biology, pharmacy, etc

2、5年以上蛋白纯化相关工作经验，其中2年以上管理经验，有中试或 cGMP 生产经验优先；

More than 5 years working experience in protein purification, including more than 2 years management experience, pilot or cGMP production experience is preferred

3、掌握现行药品管理法、相关技术指导原则的技术要求；

Master the technical requirements of current drug management law and relevant technical guidelines

4、具备解决问题的能力，具备较强的学习能力、组织协调能力和团队领导力；

Have the ability to solve problems, strong learning ability, organization and coordination ability and team leadership