TJ009 Documentation Specialist

TITLE:            Documentation Specialist 文件管理员

LOCATION:  Tianjin, China

REQ#:                         TJ009

Company Overview: Jecho Biopharmaceuticals Co., Ltd. is a biopharmaceutical company manufacturing innovative therapeutic biologics to address a broad range of infectious diseases as well as treatment of cancer. The company headquarter is located in Tianjin China.

Responsibilities:

  • Set up and maintain the documentation control system to support the quality management system running.
  • 设置和维护文档控制系统,以支持质量管理体系运行
  •  Issue and print the hard copies of the documents, forms, logbooks in the GMP requirement.
  • 按照GMP要求分发并打印文件,表格,日志。
  • To be responsible for the electronic document management system.
  • 负责电子文件管理系统。
  • To run the other quality databases.
  • 运行其他质量数据库。
  • Management the projects and equipment archive.
  • 管理项目和设备档案。
  • Manage the GMP archive.
  • 管理GMP归档。
  •  Conduct the training to employees in the field of GMP requirement on document control.
  • 根据GMP的要求在文件控制方面对员工进行培训

Minimum Requirements:

  • University degree on relevant majors.
  • 相关专业本科以上学历。
  • English writing, reading and speaking skills.
  • 具备流利的英语听说读写能力。
  • At least 5 years working experience in the relevant position.
  • 至少五年类似职位的相关工作经验。
  • Experience from a cGMP pharmaceutical company is preferred.
  • 具有生物药物企业cGMP经验者优先
  • Strong ability to work collaboratively in a team based environment, Strong communication skills, Strong ability to work in an effective and flexible way.
  • 具有较强的团队合作能力,良好的沟通能力,掌握灵活有效的工作方式。