BioNTech SE

合规和培训主管

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

岗位职责:

  • 负责车间合规和培训体系的搭建;
  • 梳理审查车间管理规程及SOP,主动识别、评估、监测和报告车间GMP合规风险;
  • 负责车间现场巡检,跟踪发现项整改完成情况;
  • 负责对车间开展GMP合规自查或外部GMP检查,对缺陷项进行分析,协调资源,主导完成整改;
  • 收集部门培训需求,根据公司及车间发展规划,制定落实公司年度培训计划和车间岗位培训计划;
  • 开发内部培训资源,组织,督促各岗位内训及培训考核;
  • 组织实施新员工培训及老员工的再培训,包括但不限于岗位SOP、SMP、MBR、OJT培训;
  • 设计、开发培训效果评价体系,量化分析总结,持续改进;
  • 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合规管理及培训相关工作经,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;
  • 了解多种培训方式和演讲能力,如何实现更好的培训效果;5. 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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