QA Officer - Anacura medical
Since April 2017
Duties in this current position include e.g. QA document writing and control, complaint and non-conformity handling, CAPA review, conducting internal audits, QA training for new employees, project work supporting continuous improvement; duties embedded within and in accordance to the medical laboratory QMS and ISO 15189 guideline for medical labs.
CMC Technical Writer
September 2016 --- March 2017
Key responsibilities in this position included the preparation, writing and editing of technical documentation relating to CMC and biopharmaceutical development activities in compliance with regulatory guidelines.
Advisor clinical trials
April 2013 --- August 2016
Key responsibilities in this position included drafting and editing of regulatory clinical trial documentation (EC and CA applications, review of study contracts), funding applications and providing advice and training to principal investigators and study coordinators.
Scientific researcher (PhD)
October 2009 --- March 2013
Key responsibilities in this position included cooperating in scientific field- and laboratory work, data collection and analyses within a EU project, scientific writing and presenting research.
Administrative help (student work)
June 2006 --- January 2009
during summer periods
Skills and Expertise
Create SOPs Develop clinical trial protocols Interact with physicians Interact with nurses Report data Search literature on clinical trials Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdministrative supportAdverse event reportingApprove patient informationArchive documentationAssemble regulatory applicationsAssist study siteAttend seminars, courses and meetings within and outside the companyClinical data collectioncollaborate in research projects at universitiesCollaborate with principal investigatorCommunicate with sponsorConduct literature searchesContract approvalCoordinate with the ethics commiteeCreate study documentsDocument data collection systemdrafting grant applicationsEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesInformed consent processLate-stage regulatory filing (MAA, BLA)Maintain Quality Management System (QMS)Manuscript preparation and reviewOrganise meetingsPrepare internal auditsRegulatory documentationStatistical analysisTrain Staff
Doctor in Biomedical Sciences in from Ghent University in 2013
in from Karl Franzens University of Graz in 2009
Master Biomedical Sciences in from Ghent University in 2009
Latijn-Wetenschappen in from Sint-Bernarduscollege in 2004
Training and Certification
GMP in 2017 Training
ISO 15189 in 2017 Training
Academic writing in 2013 Training
GCP in 2016 Certification
Coordinator Clinical Studies in 2013 Certification