Brussels, Brussels Region, Belgium
Over 8 years of experience in performing, integrating and following on Quality Management System.Today, I'm working for an pharmaceutical industry in a Quality Assurance department for Clinical Trials Supply. Expertise of standards ISO 9001, 14001, Good Manufacturing Practice, Good Laboratory Practice Knowledge of standards ISO 22000, OHAS 18001 Expertise of tools : risks analysis HACCP, internal audit, quality indicators, dashboards, AMDEC fluent english Pack office, Outlook, Gestion Electronique des Documents, Logistic Manager
I advise the devices and delivery system development laboratory and coordinate the implementation and the follow-up of a Quality Management System for the non GMP activities. I lead the development and the implementation of the necessary system to support the QMS.
I ensured the support of all activities related to QA release of the Investigational Medicinal Product (IMP) : review of the batch records, review and update of the related documentation, facilitate resolution of manufacturing issues, sample inspections. I evaluated the temperature excursions for IMP
I supported the packaging team in it's improvement's initiatives (implementation of an electronic batch record, establishment of packaging methodologies) I ensured the preparation of the studies with supply chain, prepared, updated and released documentation for packaging activities. I performed activities related to compliance including deviations, investigations, CAPA management and change control management within the packaging team.
I executed the technical transfer of one step manufacturing API, between an external manufacturing site and the analytical laboratories as QA lead. I also performed annual product quality review executive summary.
I'm executing the qualification of mobiles vessels including the Factory Acceptance Test in the supplier factory in Ireland (for 6months) : operationnal and documentary tests.
Responsible for quality aspect of the site, I manage the quality system and make a request for sanitary approval, in context of resistance to change. My function is to ensure the continuous improvement of internal services, product quality and customer satisfaction. • Internal auditing of manufacturing and documents process • Piloting monitoring plans of cold chain • Setting up the quality system: developing the documentary system and keeping it up to date, drafting the internal quality manual according to ISO 9001, making staff awareness of the internal requirements and the customers. • Following evolutions and improvements: conducting a quality dashboard, realizing and analyzing quality indicators, organization and conducting quality bimonthly meeting and weekly reporting of the quality performance review • Identifying non-conforming products, supplier’s alerts quality and ensuring that they are place on restriction • Handling customers complaints