BioNTech SE

MAH质量运营经理

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

岗位职责:

  • 负责MAH质量体系建设中运营板块的建立与维护;
  • 负责MAH委托生产质量监督管理的建设与执行;
  • 负责MAH委托生产中的偏差、变更与CAPA的管理和审核;
  • 负责MAH委托生产批记录和检验记录的审核;
  • 负责MAH委托生产日常业务的沟通和跟进;
  • 参与第三方或药政审计接待与准备工作,及后续的回复;
  • 负责收集委托生产中产生的数据并进行趋势分析及持续改进;
  • 负责与受托生产工厂配合持续提升委托生产的质量管理水平
  • 负责产品上市放行前的审核工作
  • 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;
  • 制药行业质量运营管理相关工作6年以上,其中生物药质量体系2年以上;
  • 良好的英文读写能力;
  • 英文CET-4以上。
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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