Basel, Basel, Switzerland
I am a Senior QA Expert with over 9 years of experience in quality assurance for leading biopharmaceutical companies. My expertise includes deviation and investigation management, OOS process ownership, and implementing data-driven solutions to improve compliance and efficiency. At Lonza and Boehringer Ingelheim, I led global QA processes, supported audits and inspections, and optimized investigation workflows using Lean Six Sigma principles. Skilled in Trackwise and Tableau I developed custom KPI dashboards to drive informed decision-making. Passionate about continuous improvement and new technologies in QA, I thrive on turning complex challenges into scalable solutions.
Responsible for ensuring the quality and compliance of biopharmaceutical products. My main areas of expertise are: - SME for OOX process - SME for deviation management - Deviation and investigation management - Change control management - Method validation - Trendreports - LEAN management
QA oversight of Quality Control and Quality Support Units. - Deviation management (incl. OOS and Complaints) - Involved in streamlining project of the OOX process - Change control (supporting a recent change from a local to a global process) - QA oversight of intercompany deviations, OOX and change requests (accross BI sites) - Trackwise (incl. support for other users and queries/metrics for audits/inspections) - Batch record review (analytical batches) - Supporting audits and inspections as expert
- Discrepancy management: deviation, OOX and CAPA - Helped streamline deviation/investigation process - Created metrics and KPIs using Trackwise, EXCEL and Tableau - Created a deviation data evaluation tool used Python programming
PhD Program 'Regenerative Sciences' Institute of Experimental Hematology Research area: hematopoietic gene therapy, stem cell biology and T-cell leukemia.
Research area: neurobiology, learning and memory.