BioNTech SE

QA项目副总监

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

岗位职责:

  • 全面负责新建厂房项目的验证管理工作,起草与管理项目验证主计划;
  • 负责管理第三方验证服务商的验证活动;
  • 负责协调资源,按项目进度完成验证的实施;
  • 负责审核/批准原液扩建厂房/设施/设备的URS,各类验证方案与报告;
  • 负责审核/批准计算机化系统(如称量系统、标签系统等)的URS,各类验证方案与报告;
  • 负责处理验证相关的质量事件,包括但不限于偏差、变更、CAPA等;
  • 协助支持工厂验证活动的执行与验证体系的优化;
  • 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15年以上,硕士可放宽至10年以上;
  • 工作满15年以上,具备抗体药品厂房新建项目验证与计算机化系统验证的经验;
  • 英文CET-4以上,听说读写熟练。
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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