09/25/2026 updated
100 % available
Freelance QA Compliance Consultant | GMP, GDP, GxP | Pharma | 10+ years experience
Amersfoort, Netherlands
Germany +3
Bsc. Pharmaceutical Business Administrationinfo: Germany, United Kingdom, Belgium, Netherlands
About me
Dutch QA consultant based in Amersfoort. I like turning complex GMP/GDP requirements into practical, workable processes, and I work closely with QA, warehouse, supply chain and manufacturing teams to get everyone on board. Available now for interim and project assignments in the Netherlands.
ComplianceVerification and Validation (Software)Validation ProtocolsGXP
Independent QA compliance consultant with 10+ years in pharmaceutical manufacturing, distribution and laboratory quality assurance at Novartis, Lonza, Eurofins, Centrafarm and Alloga | Cencora.
I help pharma and life-science organisations get inspection-ready and stay compliant:
- GDP gap assessments benchmarked against the EU GDP Guidelines
- Harmonising local site procedures with Global Quality standards
- Change control, deviations, root cause analysis and CAPA
- Supplier and raw-material qualification across the product lifecycle
- Audit preparation, self-inspections and external audits
- QMS improvement, SOP development and product lifecycle compliance (NPI, transfers, withdrawals)
- Batch record (BMR) review against the registration dossier
Trained GDP Responsible Person (Pharmatech, 2020) and certified in external audits and self-inspections (PCS, 2022). Every audit I prepared at Centrafarm ended with a satisfactory outcome, and at Vandeputte Medical the GDP licence was renewed after a favourable health authority inspection.
Key skills: GMP, GDP, GxP, EU GDP Guidelines, Responsible Person (RP), Quality Assurance, Change Control, CAPA, Deviation Management, Root Cause Analysis, Supplier Qualification, Audit Preparation, Inspection Readiness, Gap Assessment, QMS, SOP Development, ISO 9001, Trackwise, SAP, Data Migration, Project Management.
Industries: pharmaceuticals, biotech / CDMO, pharma distribution and logistics, laboratory services.
Languages: Dutch (native), English (fluent), Spanish.
Experience
Professional experience10+ years
Freelancer since2020
Languages
EnglishFluentDutchNative speakerSpanishGood
Project history
- Conducted a GDP gap assessment across distribution operations, benchmarked against the EU GDP Guidelines (warehousing, transport, quality processes)
- Drove process improvements to strengthen compliance and inspection readiness
- Led harmonisation of local site procedures with Global Quality standards
- Supported QA, warehouse and logistics teams through the transition to harmonised procedures
- Maintained compliance across the full product lifecycle: new product introductions, transfers and market withdrawals
- Managed cross-functional product launch and data migration projects with QA, supply chain and IT
- Handled changes, deviations, root cause analysis and CAPA implementation
- Performed BMR vs registration dossier compliance checks prior to market release
- Led audit preparation for numerous audits, all with a satisfactory outcome
- Led supplier qualification so only qualified materials and equipment were used for clinical and commercial manufacturing
- Maintained the process across the product lifecycle, from technology transfer to commercial manufacturing, including review of material assessments for release
- Reported qualification status to internal stakeholders and clients, and resolved obstacles against client timelines
- Performed change control assessments, provided deviation feedback and reviewed risk assessments in the QMS
Certificates
Product Transfer
ECA2025
External Audits & Self-Inspections
PCS Pharmaceutical Consultancy Services2022
GDP Responsible Person (RP)
Pharmatech Consultancy2020