Thermo Fisher ScientificManufacturing System Officer
Jan. 2021 - Jun. 2021Groningen, Netherlands• Resolve process and product cGMP/cGDP deviations within the given time frame (holding RAPID meetings to determine if the event is a deviation or not, conducting an investigation, interviewing stakeholders, performing RCA, suggesting CAPA when needed, performing reoccurrence checks, writing reports). • Working according to EH&S, Quality and cGMP regulations.
• Collaborating closely with different departments (DSP, USP, MBP, maintenance, engineering, QA, QC) and their members (technicians, officers, engineers, SMEs, supervisors, managers).
• RC tools used: Why-Why, Fishbone / 6M / 5M1E, Is/Is not, Brainstorming, Fault Tree.