Experience

Novitan

• Belgium
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Manager Clinical Supply

  • Jul 2022 - Present



EUROTRANSPHARMA

• France
• Truck Transportation
• 100 - 200 Employee

• Quality Manager & RP

  • Jun 2021 - Jul 2022



Movianto

• United Kingdom
• Transportation, Logistics, Supply Chain and Storage
• 700 & Above Employee

• Quality Manager

  • Jun 2019 - Jun 2021

• Qualified Person

  • Oct 2014 - Jun 2021

  As Qualified person/QA Officer I am responsible for the releases of the manufacturing activities within Movianto BE and ensuring manufacturing is performed in line with cGMP. As Qualified Person I am registered at FAMHP as the back-up Qualified Person (GMP) and back-up Responsible Person (GDP). Together with the QA manager I'm responsible to further improve the QA department by:- Ensuring manufacturing activities in line with cGMP- Ensuring Movianto BE activities are in line with cGDP- Ensuring releases of manufacturing activities at Movianto BE (Benelux)- Ensuring that an effective quality management system is operating for GMP activities- Ensuring that all regulatory obligations of the manufacturing authorization holder are fulfilled- Providing regulatory input related to manufacturing authorization updates- Providing QA and GMP/GDP training- Providing QA and GMP/GDP consultancy if needed- Performing and participating in inspections and client/supplier audits- Handling Change Controls Request and Approving GMP/GDP critical Change Control Requests- Ensuring traceability of the products in line with cGDP- Applying high ethical standards and professional conduct with clients and with the HAs- Handling complaints and deviations- Ensuring traceability and follow up of recalls on clients request- Improving the Quality Systems within Movianto BE- Helping the QA team with other tasks- Being back-up for QP/RP and QA Release Assistant- Performs self-inspections according to the self-inspection plan Movianto BE



Qualiphar NV

• R&D Engineer Process Development and Validation

  • Mar 2014 - Oct 2014

  - Development, upscaling and validation of the manufacturing process of solids, semi-solids and liquids- Write process validation protocols and reports in close collaboration with other departments- Evaluate analytical results and give guidance to lab technicians where needed- Give input towards production to ensure/guarantee an effortless and correct manufacturing process- Essential link between Research & Development, Regulatory Affairs, Production, Quality Assurance and Quality Control- Actively involved in the formulation of new products and the reformulation of existing products (cosmetics, vitamins, medicinal products for human use,...)- Actively involved in internal and external development projects- Contact with colleagues from our French sister company



Takeda Christiaens

• Trainee Industrial Pharmacist

  • Aug 2013 - Feb 2014

  - Follow-up stability studies and write stability product quality reports (PQRs)- Handling of stability related OOS/OOT/DEV/CR- Write and evaluate validation protocols and reports- Write and evaluate analytical method transfer protocols and reports- Evaluate/update analytical methods and launch new (internal) analytical methods- Actively involved in development projects at lab and industrial scale - Problem solving - Follow-up stability studies and write stability product quality reports (PQRs)- Handling of stability related OOS/OOT/DEV/CR- Write and evaluate validation protocols and reports- Write and evaluate analytical method transfer protocols and reports- Evaluate/update analytical methods and launch new (internal) analytical methods- Actively involved in development projects at lab and industrial scale - Problem solving



Universiteit Gent

• Master after master Industrial Pharmacist

  • Sep 2012 - Jun 2013

  Thesis “Continuous melt granulation: the influence of process and formulation parameters on granule characteristics”Department of Pharmaceutical Analysis, Faculty Pharmaceutical Sciences (Ghent, University of Ghent), Laboratory for Pharmaceutical Process Analytical Technology (PAT) Thesis “Continuous melt granulation: the influence of process and formulation parameters on granule characteristics”Department of Pharmaceutical Analysis, Faculty Pharmaceutical Sciences (Ghent, University of Ghent), Laboratory for Pharmaceutical Process Analytical Technology (PAT)



Apotheek Ophasselt

• Substitute Adjunct Pharmacist

  • Jul 2012 - Aug 2012



Apotheek Rousseau

• Traineeship Pharmacist

  • Jul 2011 - May 2012