Belgium
Motto: Curiosity makes the difference Me in a few words: quality oriented, efficient, open-minded team player...
• QA Product Lead on commercial Rare Blood Disease products • QA Lead on activities in aseptic manufacturing of Rare Blood Disease Products • QA Lead on Product Transfer to CMO • QA Lead on related qualification and validation programs • Responsible for preparation of batch certification • Ensuring customers expectations are followed and fulfilled • Day-to-day liaison with internal and external customers for quality related activities • Maintaining an open and effective communication with external and internal clients • Reduced turnaround times • Improvements on Business Intelligence application • Improved communication with external clients • Ensuring compliance with EU/US cGMP guidelines and applicable regulations/directives • Establishing Key Performance Indicators and metrics regarding activities • Responsible for adherence to the production schedule for QA operational tasks
• Implementation of an ISO13485 compliant Quality Management System • Topic: Software as a Medical Device (SaMD) • Managing complex, multiple, competing priorities • Managing a team of QA Officers • Ensuring compliance with EU/US GxP, ISO 13485 guideline and applicable regulations/directives • Auditing of contractors and service providers • Management of CSV and qualification programs • Management of Quality Technical Agreements with CMOs • Establishing Key Performance Indicators and metrics
• Managing a team of QA Officers • QA Lead on PPQ and BLA activities in aseptic manufacturing of Cell and Gene Therapy Products • QA Lead on the implementation of a Laboratory Information Management System (LIMS) • Responsible for preparation of QP batch release and certification • Ensuring customers expectations are followed and fulfilled • Day-to-day liaison with internal and external customers for quality related activities • Maintaining an open and effective communication with external and internal clients • Improved communication with external clients and reduced turnaround times • Ensuring compliance with EU/US cGMP guidelines and applicable regulations/directives • Establishing Key Performance Indicators and metrics regarding activities • Responsible for adherence to the production schedule for QA operational tasks • Recruitment and putting in place individual development plans
• Lead auditor external suppliers, service providers and partners • Support of >40 inspections (2x FDA) and audits. • QA Project Lead: responsible for EU/US/JP cGMP, regulatory compliant and timely release of API for sterile parenteral. Review of executed batch documents. • Responsible for batch release and issuance of release certificates. • Deviation handling, Risk and impact analysis, Change management • QA Project Lead: Process validation/PPQ; Computerized system validation (CSV) • Development and management of Quality Technical Agreements
Research for the Life Science Industry • Project Management of in vitro & in vivo tissue engineering studies (GDP/GLP) • Managed a team of 3 to deliver research targets • Planning, coordination and supervision of projects • Scientific publication in an international journal • Work on Tissue Engineering products • Characterization of biomaterials (e.g. nanoindentation) • Training in Laboratory Animal Science