Description

1QA现场巡检(生产、工务、仓库、实验室等)，包括按照武田全球要求针对DI进行巡检，针对巡检发现项与相关部门进行有效沟通，协助其制定整改措施，并对整改的完成情况进行跟踪，确保QA巡检的有效性
Perform Quality on the Shop floor (production, engineering, warehouse and QC lab etc), including DI inspection in accordance with Takeda global requirements.Communicate effectively with relevent deptartments about the daily inspection, support to develop correction action plan and follow up on the completion of the actions. Ensure the effectiveness of QA daily inspection.

2监督GMP、SOP的执行符合法规和Takeda要求；建立和维护QA相关SOP，并对相关人员实施SOP培训
Supervise implementation of GMP and SOP, ensure it meet regulatory and Takeda requirements. Establish and maintain QA related SOP, provide trining to relevent personal.

3参加global会议，针对global SOP进行工厂文件差距分析
Attend global meeting, conduct local SOP gap assessment with global SOP.

4进行批生产、批包装记录的审核，作为转授权人进行原辅料、包装材料、半成品及成品的批处置
Carry out batch production record review and batch disposition for raw material, pac...