Quality System & Compliance Engineer

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Job Description

1Establish project validation master plan for the new facility, utilitie, equipment and instrument to ensure they are all adequately validated.
建立项目验证主计划以确保新设备、设施、设备以及仪器等实施适当的验证

2Implement validation activity and QA oversight for the new project, including review relevant validation document such as FS, DS, FAT, SAT, IQ, OQ, PQ,batch record and coach the validation team to prepare protocol and report to ensure the new facility, manufacturing equipment and testing equipment is qualified or validated.
实施新项目验证活动以及QA现场监督，包括审核相关验证文件例如FS,DS,FAT,SAT,IQ,OQ,PQ,新产品批记录，指导验证团队准备验证方案和报告以确保新厂房设施、工艺设备、仪器设备经过相应的确认或验证活动。

3Responsible for reviewing or approving GMP related validation protocol and report, and supervising implementation process to comply with regulatory requirements.
负责审核或批准GMP相关验证方案和报告，监督实施过程确保符合法规要求。

4Coordinate and/or approve change control/CAPA etc, follow up on the change and CAPA execution until closure.
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

5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.

6参与、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.

7参与法规部门质量沟通，起草申报、备案、情况说明等质量相关公文。协调新产品法规抽检沟通事项。与注册部门工作对接.
Participate in quality communication with HA, draft official quality documents related to application, filing, clarification, ect..Coordinate during regulations sampling for new products. Work with Registration affairs as TJTP's interface.

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