招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
1.Develop and maintaining VMP and ensure it update to the latest status of plant
创建、维护VMP以确保更新工厂的*新状况
2.In Charge of validation & qualification protocol (DQ, IQ, OQ and PQ) and report.
负责验证,确认方案和报告的编写(DQ, IQ, OQ 和 PQ)。
3.Provide training to related departments on the development and execution of validation protocols.
给相关部门提供验证方案的培训。
4.Perform validation & qualification activities to ensure the process/system/equipment meeting it’s predetermined specification and quality characteristics.
执行验证和确认活动以保证工艺/系统/设备满足预先设定的标准和质量属性。
5.Follow up deviation found in validation & qualification to ensure the deviation is closed properly and on time.
对验证和确认中发现的偏差进行跟踪以保证偏差是正确及准时的关闭。
6.Look into the latest validation requirement and make gap analysis refer to the current status.
观察*新验证需求和根据现行状态分析差异。
7.Other tasks assigned by quality manager.
质量经理安排的其他工作事宜。
-College degree or above
大专以上学历
-Mechanical engineering, medical
devices and other validation related major is preferred.
机电工程类,医疗器械等验证相关专业优先.
-more than 2 years experience of quality management for medical device related industry
2年以上医疗行业质量相关工作经验优先
-2 year of validation experience
2年以上验证相关经验
-ISO13485, GMP and related medical device regulation knowledge
熟悉ISO13485, GMP等医疗器械相关的法律法规
-Good English reading, writing and speaking
良好的英语听、说、读、写能力
-PC skill including Microsoft
良好的计算机能力
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