Responsible for maintaining corporate training system, to ensure the system meets the requirements of NMPA, EMA and FDA GMP regulatory & Corporate Quality Manual, and make continuous improvement 负责维护公司的培训管理体系,确保体系符合中国,美国和欧盟GMP法规和企业质量手册的要求,并进行持续改进 2. Responsible for gathering training request and maintain personnel training matrix 负责培训需求的收集和维护人员培训矩阵 3. Responsible for managing trainer and training materials, organize GMP training. Coordinate the effective implementation of site training and personnel qualification 负责管理培训师和培训材料,组织GMP培训。协调工厂培训和人员资质确认的有效实施 4. Responsible for maintaining training record and training file 负责培训记录和培训档案的管理 5. Responsible for Computerized Training System routine maintenance. 负责公司计算机化培训管理系统 日常维护 6. Responsible for training data analysis and summary to support the continuous improvement training program in corporate 负责定期分析和总结培训数据,以支持公司培训系统持续提高 7. Commit to EHS regulatory compliance for the function Operation 在部门工作中遵守环保、健康与安全的法规要求 8. Completing the other activities assigned by the leader 完成领导交给的其它工作 1. Bachelor’s degree or above required in a relevant discipline (Pharmaceutical, Pharmacy, Biology or related) 大学本科以上或同等学历,制药、医药、生物或相关专业 2. Minimum 3 years the experience of quality management, including training system management 3年以上制药质量管理工作,有培训体系管理经历 3. Fluent writing and reading ability in English, speaking skill is preferred, 流利的英语读、写能力,有英语口语交流能力者优先 4. Skilled in Office software 熟练掌握office办公软件 Experience in TMS and HA inspections, comprehensive knowledge and understanding of regulatory requirement (NMPA, USFDA and EMA etc.) 具备培训管理和相关法规检查的专业经验,丰富的知识以及对法规要求充分理解(包括中国药监法规、美国和欧盟药监法规) 5. Practical experience in QS owned processes such as TMS. 具备负责计算机化质量系统的实践经验,包括培训管理系统。 6. Proven ability to engage, motivate and develop workforce 专注、积极、上进