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质量工程师(CHU)-上海 (上海, 中国)

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质量工程师(CHU)-上海-00000N9S

说明

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. As a QA Engineer, maintain and improve Franchise Complaint Handling System in JJMS and JJMC

作为质量工程师负责维护并发展JJMS/JJMC的投诉处理体系。

§ Understand CV requirements from 1) Corporation; 2) Originating Company; 3) Applicable government/health authority regulations;

充分理解总公司,母公司,及相关各国政府法规对投诉处理的要求。

§ Assist Manager to establish/optimize/implement documented system to meet relevant requirements.

协助经理建立,优化,实施相关文件体系以符合相关要求。

§ Alerting manager timely when significant issues are identified.

当出现重大情况时,及时通知经理。

§ Review KPIs monthly and provide initiative & implement improvement action timely.

每月审阅主要投诉指标,必要时及采取改进措施。

§ Participant internal audit for CV.

参与所有与投诉相关的内审。

2. Complaint handling

负责投诉处理

§ Timely report complaint, gather and send accurate and sufficient information, and samples for complaint cases as per requirement.

根据要求按时上报投诉,收集投诉描述,准确足够的住处及样品。

§ Complaint handling follow-up GOP/SOP/WI of CV on timeframe/relevant requirements meet KPI target and try to get better outcome.

根据相关投诉的GOP/SOP/WI中规定的时间表及相关要求处理投诉,达到相关的投诉指标,并且不断加以改善。

§ Review resolution form for imported goods to evaluate logical investigation has completed, discuss with upper management and follow-up originating company if necessary.

审阅所有进口产品投诉的分析报告,以确保其合理性,必要时与上级经理或相关母公司进行沟通。

§ Prepare Monthly CV summary of responsible Franchises per specific format.

以特定格式准备各部门投诉月报。

§ Have a tending analysis for related product in monthly report

在月报中对相关产品进行投诉趋势分析。

§ Proactively participant CV knowledge learning via various way - e-net; case study; classroom training; self-learning.

通过各种途径学习有关知识,学习方式包括网上学习,案例分析,产品培训,及自学。

§ Carry out complaint handling training to relevant staffs.

对相关人员进行投诉处理培训。

3. Fulfill other tasks assigned

执行某些特殊项目。

4. Comply with EHS & ISO14001

确保符合EHS 及ISO14001的要求。

资历
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EDUCATION AND EXPERIENCE

§ Bachelor degree on pharmaceutical or related subjects.

药学或相关专业学士

§ 1-2 years experience in quality compliance or related areas in medical device or pharmaceutical industries.

§ 1-2年相关工作经验

ESSENTIAL SKILLS AND ABILITIES

§ Good communication skills and learning ability

良好的沟通和学习能力

§ English fluent in reading, writing, oral, listening.

流畅的英文听说读写能力

§ Familiar with routine operations of computer and software.

流畅的英文听说读写能力

§ Familiar with routine operations of computer and software.

熟练电脑操作能力

主要地点: 亚太地区-中国-上海-上海

组织: - 强生(上海)医疗器材有限公司

工作: Quality Assurance

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