BioNTech SE

文件和偏差主管

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

岗位职责:

  • 建立车间偏差/变更/CAPA管理流程;
  • 对车间相关人员进行偏差/变更起草的培训;
  • 协助完成车间偏差/变更的起草,审核;
  • 跟进车间偏差/变更/CAPA等执行,确保偏差/变更/CAPA能按时关闭;
  • 定期对车间偏差/变更进行分析、总结和评价;
  • 负责车间文件和记录的领用,发放,回收,归档和备份,保证文件的安全性,保密性和有效性;
  • 跟踪车间文件签批进度,确保文件/记录在规定时间内完成修订及生效,以保证生产高效,有序进行;
  • 领导安排的其它工作。

任职要求:

  • 熟悉大分子生物制剂车间GMP要求;
  • 8年以上药企业GMP文件或现场管理相关工作经,外企或国内头部生物药企业工作经验优先;
  • 熟悉国内外GMP法律法规;
  • 熟悉GMP质量体系与文件体系,偏差,变更的处理;
  • 积极上进,学习能力强,执行力强,有大局观,工作效率高,善于沟通;
  • 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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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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