QA Specialist(FUME)
职位编号 C11130023
行业 制药/医疗
类型 医疗设备/器械
所在地 苏州
职位描述:

1、Responsible for reviewing FUME system corrective and preventive maintenance activities;
2、Responsible for reviewing FUME system daily logbook;
3、Responsible for reviewing FUME system periodic reviews;
4、Participate in gap assessment towards GMP and global/local quality/engineer standards and follow up with the implementation;
5、Providing appropriate oversight and support to FUME related projects and improvement initiatives;
6、Participate commissioning and qualification for FUME and review/approval related documents;
7、Ensure the direct quality impact systems are maintained in a qualified status. (Purified Water system, HVAC, Compressed Air, Manufacturing and Packaging equipment etc);
8、Other tasks assigned by supervisor。

职位要求:

1、Bachelor degree or equivalent in engineering, scientific, or pharmaceutical background;
2、Experience in operation,maintenance or quality assurance in manufacturing utilities,facilities, production equipment (FUME) more than 3 years;
3、Experience in commissioning and qualification;
4、Chinese and English capability for communication and documentation。

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