4.1.负责工厂数据完整性体系的维护及提升,建立、修订和批准相关管理流程及记录,确保工厂数据完整性管理持续符合cGMP及数据完整性相关法规要求;
Responsible for data integrity management system maintenance and enhancement, establish, revise, review and approve relevant management procedure and record to ensure site data integrity management meets cGMP and relevant data integrity regulatory requirements continuously.
4.2.监督落实工厂数据完整性管理措施的实施,监控工厂数据完整性合规状态,推动工厂数据完整性文化,持续提升工厂员工数据完整性合规意识。
Drive site data integrity management activities implementation, monitor site data integrity compliance status, launch site data integrity culture and enhance employee data integrity compliance mindset continuously.
4.3. 参与工厂新项目建设及新流程搭建,确保数据完整性从项目设计直至整个项目期均得以充分考虑。
Involve into site new project and new process establishment, ensure data integrity is considered appropriately from project design throughout the whole project phase.
4.4.负责支持药明合联各类GMP审计和检查工作。
Responsible for supporting WuXi XDC GMP audits and inspections.
4.5.监督负责区域以及下属员工所有相关人员都已经过必要的上岗前培训和继续培训;
Monitor and ensure necessary pre-job training and continuing training is received and completed for subordinates and personnel within oversight areas.
4.6.确保记录的保存,确保各种数据符合数据可靠性要求;
To ensure record keeping, ensure all kinds of data meet data integrity requirements
4.7.支持QA项目管理以及其他团队的相关的工作。
Support QA project management and other teams’ relevant works.
4.8.承办领导交予的其他任务。
Deal with other tasks assigned by line manager.