Welcome to APC
Freelance QA Consultant. With over ten years of experience in the pharmaceutical industry, I offer flexible and reliable quality assurance support – from deviation handling to batch release and audit preparation.
About Me
Dedicated to quality, compliance, and continuous improvement within the pharmaceutical sector.
Experienced Quality Officer
I am a seasoned Quality Officer with extensive experience supporting pharmaceutical companies in GMP/GDP compliance, batch review, CAPA management, and QMS remediation. Throughout my career, I have worked with industry leaders like Eurocept Pharma, Janssen Biologics, and TEVA Pharmachemie.
My strength lies in a hands-on, detail-focused approach, combined with strong knowledge of systems such as SAP, MES, sIDMA, Trackwise, and Veeva Vault. I am results-driven, highly adaptable, and capable of working efficiently in diverse QA environments, including high-pressure settings like COVID-19 vaccine production.
Education
- BSc in Pharmaceutical Business Administration – University of Applied Sciences Utrecht
- Pharmacy Assistant Level 4 – ROC of Amsterdam
Systems & Software
- SAP & MES
- sIDMA
- Trackwise
- Veeva Vault (QualityDocs)
Languages
- Dutch
- English
- Arabic
My Services
Professional QA support on a project basis or as an interim solution for your organization.
Batch Review & Release
Documentation control in SAP, MES, and paper-based systems in preparation for batch release.
Deviation Management
Conducting thorough root cause analysis and setting up/following up on effective CAPAs.
QMS Remediation
Classification and correction of GDP/GMP deviations and optimization of the Quality Management System.
Audit Support
Preparation and guidance for inspections by IGJ, EMA, and internal audits.
Document Control
Creation, revision, and management of SOPs, Work Instructions (WIs), and QMS forms.
GDP – Support Activities
Successfully completed GDP training including RP responsibilities. Currently providing support for GDP activities under supervision. My responsibilities include:
- Applying knowledge of GDP regulations and RP responsibilities in daily QA tasks.
- Supporting the implementation of GDP-compliant processes.
- Assisting with customer and supplier qualification and document review.
- Handling documents related to deviations, CAPAs, and change controls.
- Supporting maintenance of the GDP Quality Management System.
- Assisting with traceability and status management of medicinal products.
- Supporting cold-chain documentation compliance.
- Document creation and maintenance in Veeva QualityDocs.
Work Experience
An overview of my recent roles and responsibilities within the pharmaceutical industry.
QA Officer GDP
Ferring Pharmaceuticals, Hoofddorp
Temporary support for the QA team to promote company growth.
- Performing Technical releases for shipments.
- Managing Technical Agreements with external partners.
- Creation and handling deviations with CAPAs.
- Reviewing and assessing customer qualification documentation.
QA Consultant
Eurocept Pharma
Supporting remediation of IGJ audit observations and evaluation of GDP deviations.
QA Officer NPD
Janssen Biologics
Responsible for batch release preparation for new product developments and resupply batches.
QA Reviewer
TEVA Pharmachemie
Extensive experience in reviewing batch records, environmental monitoring data, and deviation reports.
Get in Touch
Looking for a professional QA consultant to support your pharmaceutical operations? I’d love to hear from you.