任职要求Requirement
1. 具备医药或相关专业本科以上教育背景 With the education background of medicine relevant majof bachelabove
2. 良好的协调沟通能力, 英语能力良好; Good communication coordination skills, with good English ability;
工作职责JOB Responsibility:
1. 审核和QC相关的SOP、实验室检验记录、分析方法、分析方法方案及报告 Review QC related SOPs, laboratory test records, analytical methods, analytical method protocols reports.
2. 参与定期检查QC系统的审计追踪,保证数据完整性 Participates in regularly checking the audit trail of the QC system to ensure data integrity
3. 定期完成QC实验室的合规巡查,发现问题并及时 追踪完成,为QC实验室合规运行提供质量监督。 Daily quality compliance inspection of QC lab, provide quality oversight fthe QC laboratory functions.
4. 参与QC实验室相关的实验室调查、偏差,变更等质量事件的审核和行动项的追踪。 Support the review of quality event, such as deviation, CC LIR ect., track the completion of action items.
5. 支持公司内外部审计,对任何发现项提供及时的响应和跟踪。 Participate in internal external audits, Providing timely response follow-up to any assigned observations.