BioNTech SE

QC合规高级工程师

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;
  • 及时跟踪国内外法规,包括GMP、药典等,组织差距分析,制定升级方案,并跟进;
  • 对接QA,制定实验室培训机制,并组织偏差复盘,不断提升人员GMP符合性能力;
  • 及时收集并整理检测记录,对记录进行复核,及时将记录提交QA审核,再出具检测报告;
  • 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;参与周期性质量回顾,汇总和分析合规相关数据;
  • 协同QA及EHS,定期进行实验室巡检,并及时完成发现项整改;
  • 组织QC各组各类审计的应对工作,及参与制定各发现项的整改措施制定,并跟进执行;
  • 制定合规相关的实验室管理/操作文件,如QC人员培训管理规程、产品质量标准管理规程等;
  • 参与OOS、偏差调查、变更,及CAPA的制定,并跟踪其执行;
  • 参与营造良好的质量控制文化建设,并组织和推进各项措施的落实;
  • 领导安排的其它工作。

任职要求:

  • 至少3年及以上QA工作经验,至少5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;有生物制品行业工作经历的,优先考虑;
  • 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;
  • 良好的英语听说读写能力;
  • 熟练使用 MS-Word, MS-Excel, MS-Outlook等办公软件。
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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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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