BioNTech SE

QC合规工程师

BioNTech SE  •  Nantong, CN (Onsite)  •  4 months ago
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Job Description

岗位职责:

  • 协助实验室管理层建立、维护符合GMP要求的实验室质量控制体系,包括:人员培训维护及管理、仪器维护状态的管理、试剂耗材管理、文件/记录领取分发回收、实验室文件归档等,确保实验室运行符合法规要求;
  • 及时收集并整理检测记录,对记录进行复核,确保合规,及时将记录提交QA审核,完成所有审核后出具检测报告;
  • 收集并整理实验室检测数据,根据需要及时反馈给其他相关部门,如生产、QA等;
  • 协同QA及EHS,定期进行实验室巡检,并及时完成发现项整改;
  • 关注实验室效率,追踪实验室KPI,包括:OOS调查按时完成率等,并定期回顾;
  • 较强的沟通及协调能力,能及时将实验室相关信息与其他部门进行沟通;
  • 起草合规相关的实验室管理/操作文件,质量标准等;
  • 参与偏差调查、变更发起、整改预防措施执行等;
  • 协助进行实验室持续优化;
  • 领导安排的其它工作。

任职要求:

  • 本科及以上学历,生物化学,生物分析,分析化学等相关专业;
  • 至少3年及以上QA工作经验,至少3年以上实验室工作经验,有项目管理经验更佳;若为硕士,可适当放宽;
  • 熟悉法规要求,包括:各国药典、药品生产质量管理规范(GMP),及ICH Q10等;
  • 熟悉实验室仪器管理、人员培训、试剂管理、文件管理相关流程;
  • 了解生物制品或细胞产品实验室的一般检测项目的原理及要求,可以对检测记录的正确性进行审核;
  • 诚实正直敬业、工作有原则、认真细致;具备良好的沟通协调及团队协作能力,有高度责任心和强烈的服务意识;
  • 良好的办公软件使用能力,良好的英语听说读写能力。
BioNTech SE

About BioNTech SE

Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.

BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.

BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.

Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html

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🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html

Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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