BioNTech SE

QA Training Senior Specialist,Nantong-QA

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

岗位职责:

  • 负责公司GMP培训体系搭建、落地执行与持续优化,维护并各部门岗位培训矩阵、课程体系及考核标准,适配法规更新、文件变更、岗位变动等场景。
  • 统筹全员GMP培训管理工作,包括新员工入职GMP培训、在岗人员年度复训、法规专项培训等,保障全员上岗资质合规。
  • 常态化开展跨部门培训需求调研,结合年度质量目标、岗位风险、审计整改要求,制定年度、季度培训计划并落地跟进、闭环落地。
  • 负责Veeva培训管理系统日常运行,完成培训台账、培训记录、考核结果的追踪,确保培训数据真实、完整、可追溯。
  • 负责培训模块内部自检、外部审计、客户审计迎检工作,识别培训风险,落实整改与持续改进。
  • 建立培训效果评估机制,通过理论考核、现场核查等方式评估培训有效性,持续优化培训形式与课程内容。
  • 按需求输出月度/季度/年度培训工作总结。
  • 完成上级交办的其他相关工作。

任职要求:

  •  本科及以上学历,药学、制药工程、生物技术、化工、质量相关专业 。
  •  5年及以上制药行业GMP工作经验,2年及以上专职GMP培训体系管理经验,有完整培训体系搭建经验优先。
  •  熟悉中国GMP及行业指导原则,熟悉药品生产、质量系统培训合规要求,熟悉培训全生命周期管理流程 。
  • 熟练操作Office办公软件、LMS培训系统,能够独立制作培训课件、统计分析培训数据、输出报告 。
  • 熟悉药企文件管理规范,可独立完成培训流程、记录、方案的编写与修订 。
  •  具备良好的跨部门沟通协调能力、执行力与风险意识 具备基础英语读写能力 。
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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