BioNTech SE

QA Manager for QC

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

岗位职责:

  • 负责带领实验室QA团队监管QC实验室现场;
  • 负责带领实验室QA团队审核QC实验室管理文件与操作SOP;
  • 负责带领实验室QA团队负责审核QC实验室放行检测数据与记录;
  • 负责带领实验室QA团队负责审核QC实验室稳定性数据与记录;
  • 负责带领实验室QA团队审核QC实验室环境监测数据与记录;
  • 负责带领实验室QA团队审核QC实验室无效分析,偏差与OOS事件的;
  • 负责带领实验室QA团队复核QC实验室COA;
  • 负责带领实验室QA团队审核QC实验室变更;
  • 负责合同实验室的现场审计;
  • 负责带领实验室QA团队审核分析方法验证/转移方案与报告,及相关数据与记录;
  • 负责协助处理产品批放行;
  • 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;
  • 制药企业QC工作经验5-8年(硕士可放宽至3-5年)实验室QA工作满3-5年以上;
  • 制药行业质量管理相关工作5年以上,其中生物药分析经验3年以上;
  • 英文CET-4以上,良好的英文听说读写能力。
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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🔗 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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