BioNTech SE

QA Operation Manager for DP

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

岗位职责:

  • 全面负责制剂QA运营组的管理工作;
  • 负责带领制剂QA运营组执行制剂生产称量、配液、清洁与消毒、清场等现场监管;
  • 负责带领制剂QA运营组执行制剂生产管理与操作SOP的审核;
  • 负责带领制剂QA运营组执行制剂生产质量管理文件的优化与培训;
  • 负责带领制剂QA运营组执行制剂生产数据与批生产记录的审核;
  • 负责带领制剂QA运营组执行制剂生产偏差、变更、CAPA的审核,参与OOS事件调查;
  • 负责带领制剂QA运营组执行制剂产品的放行;
  • 负责带领制剂QA运营组执行制剂生产中不合格品的处理;
  • 协助带领制剂QA运营组执行制剂生产涉及的物料的放行与供应商的确认;
  • 协助带领制剂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;
  • 工作满8年以上(硕士可放宽至5年以上);
  • 生物制药行业质量管理相关工作5年以上;
  • 英文CET-4以上,英语听说读写熟练。
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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