BioNTech SE

QA System Senior Specialist

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

岗位职责:

  • 负责工厂体系文件的维护与更新,确保体系的正常运行;
  • 负责偏差、变更、CAPA和质量风险管理等合规审核;
  • 负责协助外部客户与药监机构的检查工作,及回复和整改;
  • 负责组织偏差审核会议、变更审核会议,并反馈审核结果;
  • 负责支持定期质量管理评审,分析质量体系数据;
  • 负责支持质量电子系统的上线,以及相关的质量项目的完成;
  • 负责根据新颁布法律法规的差异分析结果进行体系优化;
  • 协助工厂项目注册申报工作;
  • 完成上级领导交付的其他工作。

任职要求:

  • 本科及以上学历,生物工程、生物技术及其他制药相关专业;
  • 生物制药行业质量管理相关工作5年以上;
  • 英文CET-4以上,具备良好听说读写能力。
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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