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 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GMPSOP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OOSOOT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

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