1. Support routine production activity: maintain cleaning and flushing matrix, track and analyze production OEE and powder loss performance, maintain monthly powder transfer system usage plan, production process performance tracking and analysis on the monthly basis
2. Update Standard Operating Procedure when necessary.
3. Responsible for operations department Quality Record (QR)Preparation and Corrective Action and Preventive Action (CAPA)follow up. Ensure no overdue or impact to product release. Provide detailed production non-conformity analysis and summary on the monthly basis.
4. Responsible for Change Request initiation and follow up.
5. Responsible for Performance Qualification (PQ) preparation and support for Installation Operational Qualification (IOQ)activities.
6. Implement the regular GMP and HACCP internal assessment and set up corrective action plan and follow up. Support on preparation for the internal & external quality related audit.
7. Involve in Root Cause Analysis (RCA) of processing failure, define corrective and preventive action and complete relevant investigation report in time.
8. Support on a operation and cross functional projects: NPI, engineering project, quality related projects （P.o.P,HRP）,and operations projects(OEE, powder loss, Operations standardization, cleaning/flushing optimization)etc.