Documentation Specialist

中国, 江苏, Suzhou

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Main  Tasks & Responsibilities主要工作职责  :

Documentation control文件控制

  • Transfer existing DOM (Diagnostics Operations Mannheim) Documentation requirements to fit Asia Manufacturing needs. 转移现有的DOM(曼海姆诊断运营)文档要求,以满足罗氏诊断苏州的需求。
  • Responsible for the coordination, involvement and documentation according to timetable. 负责按照时间表进行协调,参与和完成文件。
  • Review the documents and identify gaps in qualification of the Documentation team. 审核文件,并确定文件方面的差距。
  • Support to establish the documentation control process for full operation project. 支持整个项目的文档控制流程的建立。
  • Responsible for the creation, update, optimize, distribution and maintenance of documentation to fit the Asia Manufacturing and ISO needs. 负责创建,更新,优化,分发和维护文档以满足罗氏诊断苏州和ISO的需求。
  • Assures compliance with Roche corporate requirements regarding Documentation and Records Control requirements for the quality and operations functions. 确保符合罗氏诊断总部有关质量和运营职能的文档和记录控制的要求。
  • Make cross-functional communication with related functions/departments regarding the document transfer project. 与有关文件转移项目的相关职能/部门进行跨部门沟通。
  • Submit work flow for document approval in DiaDoc (Document management system) 在DiaDoc(文档管理系统)中提交工作流程以进行文档批准。
  • Coordinate the document periodic review协调文件定期审核。

Batch record review批记录审核

  • Support to establish the batch review process for final site. 支持批记录审核流程的建立。
  • Coordinate the daily batch review tasks in the team.协调团队中的日常批记录审核工作。
  • Review Manufacturing Batch Record (DHR) and prepared the checklist. 审核制造批记录(DHR)并准备批记录检查表。


  • Perform user acceptance test进行用户验收测试。
  • Involve in OOS/Deviation , ECR(change) and CAPA process参与超标/偏差,变更和纠正预防措施流程。

Other tasks assigned by supervisor主管分配的其他工作