BioNTech SE

QA System Specialist

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

岗位职责:

  • 文件全生命周期管理: 主导GMP文件(包括但不限于SOP、质量标准、批记录、验证方案/报告等)的起草、修订、审核、批准、生效、分发、回收、归档及废止全过程,确保版本受控、状态清晰;
  • 文件体系维护与合规: 维护文件管理系统的有效运行,确保文件编号、版本控制、生效日期等符合内部程序及GMP法规要求。确保文件管理实践符合数据完整性原则(ALCOA+)及电子记录法规(如21 CFR Part 11);
  • 文件归档与数据完整性: 负责纸质与电子文件的系统性归档、存储与检索管理,定期执行存档文件的检查与回顾,确保其完整性、安全性与长期可读性;
  • 内外部审计支持: 作为文件管理接口人,全面支持内审、官方审计及客户审计,高效提供所需文件记录,并跟进文件相关的整改措施闭环;
  • 流程优化与培训: 持续优化文件管理流程,推动电子文档管理系统(EDMS)的高效应用。协助开展文件管理相关培训,提升全员文件合规意识与执行力;
  • 完成上级交办的其他工作。

任职要求:

  • 本科及以上学历,药学、制药工程、生命科学、档案管理等相关专业;
  • 3年及以上制药行业或严格GMP环境下的文件管理体系相关工作经验;
  • 熟悉GMP法规,了解FDA、EMA、NMPA监管要求;
  • 具备文件编写、版本控制、归档管理能力,熟练使用Office、PDF工具及DMS(电子文档管理系统);
  • 极强的责任心、细致严谨,具备卓越的合规意识、沟通协调能力与团队协作精神;
  • 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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🔗 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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