1. 负责无锡生物 工厂GMP人员的培训项目； Lead GMP Training program for all GMP staff within Wuxi Biologics among all sites.

2. 负责无锡生物工厂GMP培训体系的建立和维护； Set up and Maintain GMP training system in WuXi Biologics.

3. 负责维护培训相关的程序； Maintaining of Training related procedures（QSG/SOPs）.

4. 组织并开展相关GMP课堂培训； Organize and perform the related GMP classroom training.

5. 负责建立并维护部门的工作模块； Set up and Maintain Job Code for department and personnel

6. 组织及策划年度再培训活动 Develop and schedule Annual GMP Training

7. 创建并维护GMP培训文档及个人档案记录，包括培训材料，记录及个人档案； Develop and Maintain Training related files and personal binder, including training materials, records, personal binders etc.

8.负责GMP人员培训状态的跟踪，并定期汇报至高级管理层 Tracking of GMP training status，and periodic report to Sr. Management.

9. 负责培训相关电子系统项目的开发、流程维护及OJT培训（e.g. MasterControl）； Develop and maintain the electronic system related to training business and provide OJT training（e.g. MasterControl）

10. 与全球质量体系合作，实施质量战略，使各生产企业培训计划与程序保持一致Partnering with the global quality system to implement the quality and training strategy and to align training program with manufacturing sites

11. 建立并管理与培训伙伴的关系，如：培训师、培训学员 Build and manage relationship with training partner, e.g. Trainer, trainees, training coordinator

12. 参与并支持客户及法规的审计活动； Participate in and support on Client audit and regulatory inspection

13. 完成领导交办的其它工作 Any Job and responsibility assigned by direct supervisor；

要求

教育水平 （教育程度+专业要求）

Bachelor degree or above, Major in biology, pharmacy, chemistry related;

工作经验 （年限\专业经验\行业经验/管理经验）

At least 2 years QA and GMP QMS working experience in pharmaceutical industry. Relevant experience in GMP Training or QA/QC is preferred. In-depth knowledge of EMA, FDA, NMPA GMP regulations and ICH guidelines.

特殊要求 1、 Strong organization and time management skills.

2、 Competent in written and oral English

3、 Excellent interpersonal, verbal & written communication, presentation and facilitation skills.

4、 Ability to independently solve problems.

上班地址：马山梅梁路108号