职位描述
This position is primarily responsible for Quality Department’s QMS I3 project management, including communication and coordination across various teams within the department, progress tracking, and Global documents translation verification. Ensure the Quality Department’s QMS I3 project is effectively executed according to Global plan.
该岗位主要负责质量部QMS I3项目管理,包括质量部各个团队的沟通协调、进度追踪和总部翻译件的校对等,确保质量部QMS I3项目按总部计划有效执行。
Key Objectives/Deliverables:
负责质量部QMS I3项目管理
Responsible for Quality Department QMS I3 project management
与总部及工厂QMS I3项目负责人沟通,明确项目计划和时间安排。
Communicate with Global and site QMS I3 project leader to clarify project plans and timelines.
根据总部要求,及时与质量部相关团队沟通,确保受影响部门充分了解并落实要求。
Ensure timely communication with impacted teams within the Quality Department based on the requirements of Global.
追踪受影响部门项目进度,确保按计划完成。
Track progress of projects in affected departments to ensure timely completion.
校对总部英文文件的中文翻译,确保准确性和合规性。
Verify Chinese translations of global English documents to ensure accuracy and compliance.
支持APO的相关工作,如退役GMP文件,确保文件体系持续合规。
Support APO-related tasks, such as retiring GMP documents when required, to maintain continuous compliance.
其他与质量相关的事项:
Other tasks related to Quality:
负责收集质量指标数据,包括每周更新、月度质量指标等,并及时上报潜在合规风险。
Be responsible for collecting data for quality metrics, including Weekly Update, Monthly Quality Metrics, etc., and report potential compliance risk in a timely manner.
负责监测CAPA等活动的进度,及时提醒相关人员,确保按计划推进。
Monitor the progress of activities such as CAPA and provide timely reminders to relevant personnel.
负责组织和协调 Hot Topic Rehearsal 会议,并撰写会议纪要。
Organize and coordinate Hot Topic Rehearsal meetings and prepare meeting minutes.
负责组织和协调 DRB 和 CCRB 会议,确保会议高效执行。
Organize and coordinate DRB and CCRB meetings to ensure effective execution.
完成主管安排的其他工作。
Other tasks assigned by supervisor.
遵守HSE各项管理流程,履行安全生产职责要求。
Follow various HSE management procedures and fulfill the work safety responsibilities.
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕