Omschrijving

With 12+ years of experience in pharma sterile vaccines manufacturing, I support manufacturers in building robust, inspection-ready quality systems, without compromising operational efficiency.

I specialize in sterile environments, validation strategy, and contamination control, with strong expertise in Annex 1 implementation and the mindset shift it requires. My approach goes beyond compliance: I help teams embed risk-based thinking into daily operations.

Working at the intersection of science, GMP regulations, and manufacturing reality, I translate complex requirements (EU GMP, 21 CFR, ISO standards) into pragmatic, sustainable solutions that stand up to audits and to real-life constraints.

Talen

Frans
Tweetalig / moedertaal
Engels
Vloeiend
Nederlands
Beperkte professionele capaciteit
Italiaans
Basiskennis

Voorkeuren voor werkplek

Kan op locatie werken

Namur (tot 50km)

GSK GSA
External Quality Lead
PHARMACEUTISCHE INDUSTRIE
januari 2024 - januari 2025 (1 jaar)
Wavre, België
• Quality oversight and compliance during technical transfers between CMOs and GSK sites.
• Work in cross-functional teams with effective stakeholder management, fostering collaboration and clear communication with CMOs and internal teams
• Focused on mitigating risks, enhancing compliance, and supporting business growth through robust quality management in technical transfers
• Leading quality governance for transfer projects, ensuring timely issue resolution (DMAIC approach) and action completion.
• Developing and managing Quality Agreements and providing strategic quality input during regulatory inspections.
GSK GSA
QA External Supply Manager
PHARMACEUTISCHE INDUSTRIE
februari 2021 - september 2024 (3 jaren en 7 maanden)
Wavre, België
• Be the quality contact point for a CMO performing formulation, filling and visual inspection
• Ensure accountability for all quality activities linked to the CMO management (deviations, CAPA closure, risks management, release, complaints, product quality review, …)
• Ensure that Quality systems are in place/in use, routinely monitored and assessed
• Annex 1 gap assessment, USP compliance including new USP 665…
• Master quality agreement content and be accountable to fulfill the requirements
GSK GSA
Sterility Assurance Specialist
PHARMACEUTISCHE INDUSTRIE
februari 2017 - maart 2021 (4 jaren en 1 maand)
Wavre, België
• Perform risk assessment analysis (FMEA, environmental monitoring risk assessment), risk based decision making
• Continuous improvement by using lean principles (Gemba, Poka-Yoke, PDCA, 5S…)
• Develop sterility assurance competences of supervisors and operators
• Investigation and quality decision on sterility assurance issues
• Problem solving and root cause analysis (Gemba, 6M, 5 Whys…)
• Prepare and manage internal and external cGMPs and EHS audits
• Review and approbation of SOPs, review of media simulations, assessment of sterility assurance impacts in change controls, Contamination Control Strategy author