杭州招聘

岗位职责：

1. 负责上海工厂设备GMP管理；

Be responsible for ShangHai site equipment GMP management.

2. 负责生产设备的偏差、变更、CAPA和工程在线的QA的管理；

Be responsible for deviation management,chang control,CAPA and related engineering QA on-line management.

3. 负责上海工厂设备预防性维护保养法规符合性，审核设备的预防性维护计划和报告，跟踪设备预防性维护进度；

Be responsible for shanghai site GMP compliance for the equipment pre-maintenance,reviewed all equipment PM plan and report,follow up the PM execution.

4. 负责上海工厂设备检验法规符合性，审核设备校验计划和报告，跟踪校验计划执行；

Be responsible for shanghai site GMP compliance for the equipment calibration,reviewed all equipment calibration plan and report,follow up the calibration execution.

5. 负责工程和设备QA事项的跟踪；

Be responsible for following up engineering and equipment QA issues

6. 负责生产设备GMP符合性的审核；

Be responsible for the review about the equipment GMP compliance

7. 持续改善设备管理的流程，提高设备使用的效率；

Continuous improve the equipment management procedure,and increase the operation efficiency.

岗位要求：

1. 本科以上学历，生物学和药学相关学科；

Bachelor degree above,major in biology or pharmacy.

2. 两年以上设备管理工作经验；

At least 2 years of working experience in equipment management

3. 熟悉CFDA,FDA,欧盟以及ISPE PDA等法规指南对于设备管理的要求；

Be familiar with the requirements of equipment management according to the regulations and guides of CFDA，FDA,EU etc.

4. 良好的英语听说读写能力，熟练计算机使用；

Well verse in spoken and written English language,skillful in using computer software.

5. 有较强的分析问题能力及良好的沟通技巧、工作任职、细致，具有良好的团队合作精神。

Excellent communication,problem-solving,and organization skills,attentive,careful and meticulous,with strong team-work ability.

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