Lucerne, Lucerne, Switzerland
• Managed change control sub-system, ensuring register maintenance and technical folder updates for quality records. • Supported audits by preparing necessary documentation and SOPs, managing investigations and final product releases. • Negotiated quality agreements, onboarded suppliers, and trended data for management review preparations.
• Led global projects for Quality Systems & Processes at Datwyler Group • Standardized and supported implementation of business processes using process modelling tools • Maintained and updated business processes landscape in compliance with ISO standards • Supported internal stakeholders on compliance topics and managed relevant documentation
• Led closure of Supplier Quality issues for new model programmes, ensuring zero incremental score. • Implemented High Impact Supplier Launch Challenge process for suppliers with quality issues. • Developed relationships with stakeholders and suppliers to drive robust problem resolution.
• Provided technical customer support to pharma customers, ensuring timely resolution of issues • Conducted GMP audits and managed CAPA processes to maintain quality standards • Led projects and coordinated MSA studies to improve processes and customer satisfaction
• Coordinated 8D problem solving team at TDK, leading to timely resolution of customer claims. • Prepared and evaluated 8D reports, utilizing Root Cause analysis techniques like 5Why and Ishikawa. • Supervised internal responses and credit note preparation in SAP, ensuring efficient processes and customer satisfaction.