À propos du poste
The Global Quality Specialist is involved in guaranteeing the quality at international level within the entire flow from raw material to product in order to guarantee and optimize organizational standards. This person will be based in Rotterdam (Netherlands) and, as member of the Global Quality Management team, will report to the Global Quality Director.
• Perform internal audits, supplier qualification audits, prepare audit reports, update the database and provide advice in relation to the audit result;
• Coordinate and conduct Global Quality projects aiming to incorporate and improve Total Quality Management in the organization’s processes;
• Set up and keep QIS database up-to-date to achieve a uniform approach towards quality;
• Monitor the quality status of local sites through quality KPI’s and generate accurate reports and data analysis base on quality reports;
• Act as an ambassador to represent the Global Quality Management team towards regional/local quality leaders;
• Initiate Continuous improvement actions with local QA-leaders;
• Provide daily support to regional/local QA;
• Act as a point of contact to national authorities;
• Collaborate with Global Quality, the Global Procurement team as well as with the local quality teams based in Asia, Europe, and in North and South America.
• Master degree in a pharmaceutical-related discipline;
• Thorough understanding of EU GMP/FDA/ANVISA regulations;
• Knowledge of manufacturing processes in drugs/API’s/excipients;
• International and cross-functional work experience, preferably with Europe, Asia and North and South America;
• Experience as QA manager or QP is highly preferred;
• 5 years of relevant working experience;
• Fluent in English; Dutch and other language skills preferred;
• Result driven;
• Global thinker;
• A pro-active team player.
We offer a unique working environment where talent and ambition can develop to its fullest. A perfect job for a senior quality professional to apply their quality mindset and quality management skills at an international level. We have an open and informal organization culture, where you need to be able to work independently. Fagron is a young, professional and ambitious company with plenty of growth opportunities.