QA Specialist
波科国际医疗贸易(上海)有限公司
- 公司性质:外资(非欧美)
- 公司行业:贸易/进出口
职位信息
- 发布日期:2017-11-30
- 工作地点:上海-黄浦区
- 工作经验:无工作经验
- 职位月薪:8-10万/年
- 职位类别:质量检验员/测试员
职位描述
职位描述:
Complaints & Adverse Event handling management:
? Ensure over 95% complaints reported to relevant sourcing company in 4 working days;
? Ensure average complaints samples back to sourcing company within 15 days;
? Ensure 99.7 % reportable MDV (Local & Oversea) will be reported to CFDA within requirements;
Field action & QN management:
? Ensure 100% Field action will be received and analyzed it with the relevant people;
? Ensure 100% communication package localization when necessary;
? Ensure 100% Field Action will be communicated with customer according to BSC KPI. And communicated it with CFDA when necessary;
? Contact and inform regional Post-Market Surveillance Officer on Field action & QN completion;
? Tracking and Inform OPS on QN disposition timely;
Post Market Surveillance monitoring:
? Support with the traceability and recording of all compulsory related data monthly;
Quality system management:
? Support to develop and maintain BSC China procedures related to Post Market Surveillance together with QA Manager;
? Support to develop BSC China training related to Post Market Surveillance together with QA Manager;
Other tasks assigned by Department & company:
? Renew company license;
? Support RA to provide the complaint and MDV data for renew registration certificate. etc.
Complaints & Adverse Event handling management:
? Ensure over 95% complaints reported to relevant sourcing company in 4 working days;
? Ensure average complaints samples back to sourcing company within 15 days;
? Ensure 99.7 % reportable MDV (Local & Oversea) will be reported to CFDA within requirements;
Field action & QN management:
? Ensure 100% Field action will be received and analyzed it with the relevant people;
? Ensure 100% communication package localization when necessary;
? Ensure 100% Field Action will be communicated with customer according to BSC KPI. And communicated it with CFDA when necessary;
? Contact and inform regional Post-Market Surveillance Officer on Field action & QN completion;
? Tracking and Inform OPS on QN disposition timely;
Post Market Surveillance monitoring:
? Support with the traceability and recording of all compulsory related data monthly;
Quality system management:
? Support to develop and maintain BSC China procedures related to Post Market Surveillance together with QA Manager;
? Support to develop BSC China training related to Post Market Surveillance together with QA Manager;
Other tasks assigned by Department & company:
? Renew company license;
? Support RA to provide the complaint and MDV data for renew registration certificate. etc.
职能类别: 质量检验员/测试员
公司介绍
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