1.Assist in Process Validation and Technology Transfer activities to ensure the accomplishment of company goals.
2.Assist in qualification works for production equipment meeting timeline and cGMP requirement.
3.Coordinate feasibility trials and process validation activities.
4.Prepare study plans, and qualification documentations and/ or batch records assigned tasks.
5.Support production related investigation, CAPA and troubleshooting.
1. 負責全廠品質制度之規劃與執行,以確保系統與產品符合國際GMP及PIC/S法規要求。該角色的範圍還包括品質預算和資源規劃、品質績效指標/品質看板、品質策略規劃、品質目標和品質特定項目。
Responsible for planning and implementing the factory quality system to ensure that the system and products comply with international GMP and PIC/S regulations. The scope of this role also includes quality budget and resources planning, quality performance metrics /quality dashboards, quality strategic planning, quality goals& objectives, and quality-specific projects.
2. 品質系統Quality Management System - Oversee Quality Management System (QMS) activities such as customer complaints handling, deviation management, CAPAs, change controls quality risk management, etc. ensuring they are timely and effectively executed.
3. 法規系統Compliance System- Oversee and support supplier quality management program, documentation management, and training management in medical quality.
4. 稽核和查廠Audit and Inspection- Coordinate self-inspections and support regulatory authorities' inspection/client audits.
5. 品質績效指標Quality KPI - Monitor quality-related metrics ensuring their compliance with the site targets and host quality councils.
6. 跨部門活動/專案管理Cross-function activities/projects- Support cross-function activities/projects when required ensuring quality regulations and requirements are followed.
7. 主管交辦事項Assigned by supervisor