BioNTech SE

QA运营副总监

BioNTech SE  •  Nantong, CN (Onsite)  •  1 day ago
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Job Description

岗位职责:

  • 全面负责QA运营组的管理工作;
  • 负责带领QA运营组执行原液/制剂生产称量、配液、细胞培养、纯化操作、清洁与消毒、清场、原液储存等现场监管;
  • 负责带领QA运营组执行原液/制剂生产管理与操作SOP的审核;
  • 负责带领QA运营组执行原液/制剂生产质量管理文件的优化与培训;
  • 负责带领QA运营组执行原液/制剂生产数据与批生产记录的审核;
  • 负责带领QA运营组执行原液/制剂生产偏差、变更、CAPA的审核,参与OOS事件调查;
  • 负责带领QA运营组执行原液/制剂产品的放行;
  • 负责带领QA运营组执行原液/制剂生产中不合格品的处理;
  • 协助带领QA运营组执行原液/制剂生产涉及的物料的放行与供应商的确认;
  • 协助带领QA运营组执行原液/制剂产品技术转移;
  • 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12年以上, 硕士可放宽至10年以上;
  • 具备抗体原液与制剂生产的现场运营管理与监督经验;
  • 具备较好的英语听说读写的能力;
  • 良好的人员管理能力、项目管理能力,良好的沟通表达能力;
  • 较强的独立思考和分析能力,能根据实际情况提出方案;
  • 工作认真负责、考虑问题细致、有良好的团队合作精神。
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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