Omschrijving

I am a freelance Industrial Pharmacist with 18 years experience in the Human and Veterinary Pharmaceutical and Medical Devices Industry. During my career I have successfully led companies to their GMP, GDP and ISO 13485 certification, and have supported them as a Qualified Person and Responsible Person. My specialty is Quality Assurance, offering tailored solutions for Regulatory and Compliance Requirements.

Talen

Nederlands
Tweetalig / moedertaal
Frans
Vloeiend
Engels
Tweetalig / moedertaal

Voorkeuren voor werkplek

Kan op locatie werken

Ghent (tot 50km), Brussels (tot 50km), Antwerp (tot 50km)

Hyloris Pharmaceuticals
GDP support
juni 2023 - Vandaag (3 jaren)
Liège, Belgium
Training the Responsible Person in Good Distribution Practices.
Adaptation of the Quality Management System to obtain Good Distribution Practices and Good Manufacturing Practices licenses.
Quality Management System Good Distribution Practices Good Manufacturing Practices Quality Agreement Quality Assurance
Sterima
Head of QA/QC/RA Team
januari 2022 - juli 2025 (3 jaren en 6 maanden)
Kortrijk, WV, Belgium
Managing the quality team at Sterima (4 direct reports) across two manufacturing plants.
Quality Representative in the Leadership Team.
Sterilization of Medical Devices.
ISO 13485 certification of the Quality Management System.
CE certification of a new Medical Device, in line with the Medical Device Regulation (MDR).
ISO 13485 Quality Management System Quality Agreement Quality Assurance Head of Quality
Elanco Animal Health
Responsible Person and Quality Manager
februari 2020 - december 2021 (1 jaar en 10 maanden)
Antwerp, Belgium
Quality Manager for the Benelux and Nordics Affiliate regions, leading a team of two people.
Responsible Person for Elanco Belgium and Elanco Netherlands.
Obtaining two Wholesale Distributor Authorisations (WDA) and two Feed Licenses under strict time pressure.
Quality Management System Responsible Person Quality Manager Good Distribution Practices