QA Engineer

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Job 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, packaging material, semi-finished product and finished product as delegated by QP.

5参与、审核及批准相关质量事件的调查，包括但不限于偏差、OOS、OOT等。追踪质量事件调查进展，为事件根本原因及总结提供QA结论，向QA经理汇报并提供建议
Participate, review and approve relevent quality event investigations, include but not limited to deviaiton, OOS, OOT etc. Track quality event investigation status, provide QA conclusion base on investigation root cause and summary, report detailed information and recommendations to QA manager.

6协调和/或批准变更、纠正预防措施等，跟踪变更及纠正预防措施的执行情况直至关闭
Coordinate and/or approve change control/CAPA etc, follow up on the change and CAPA execution until closure.

7确保所在职能组风险管理体系的有效性，包括主动对风险进行识别、评估和制定缓解行动计划
Accountable for functional risk management, including proactive risk identification, assessment and mitigation plan development.

8周期性执行计划内的质量自检，保证相关现行法规和公司质量要求的符合性；支持公司内部和外部GxP审计
Perform planned self-inspection periodically and make sure conformity of executing relative Regulation and company quality requirements. Support internal and external GxP audit.

9负责第三方虫控供应商的现场管理，批准第三方供应商的月度报告及趋势分析报告，协调其他部门完成相关发现项的整改并对其完成情况进行跟踪
Responsible for the on-site management of 3rd party pest control supplier, approve the monthly report and trend report provided by the supplier, coordinate the other dept. to address the findings and follow up on the action completion status.

10良好的英文听说读写能力，可以独立参加Global会议并向直线经理汇报相应信息
Good English listening, speaking and writing skills, capable of independently attending Global meetings and reporting relevant information to line manager

Locations

Tianjin, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time