2018–present Industry Auditor / Consultant
- Services include audits, management support, training, coaching and advice on quality-related issues, risk management, validations and lean six sigma.
2012–2018 Pharmacist Quality Assurance / Qualified Person
University Medical Center Groningen (UMCG), Groningen
- Managing QA systems to define, implement and assure compliance to appropriate (regulatory) guidelines regarding pharmaceutical practices
- Involved as Qualified Person in development and manufacture of (biotechnological) drugs
- Planning, execution and monitoring of activities regarding medical gases
- Planning, execution and monitoring of quality related activities regarding pharmaceutical patient care and clinical research
2007–2012 QA Compliance Manager / Qualified Person
DSM Biologics (DSM Pharmaceutical Products), Groningen
- Responsible for final disposition to customers of cell banks and bulk products and managing relating activities (Qualified Person)
- Advising to project organization and customers on all relevant cGMP matters and assures appropriate cGMP level of project activities
- Managing QA systems to define, implement and assure compliance to cGMP policies for these systems, including proposing and implementation of improvements
- Providing assistance and informing departments about changes in regulatory guidelines and supporting customers in regulatory guidelines related to the submission and maintenance of their product applications and approved licenses.
- Hosting FDA and EMA audits
2004–2007 Clinical Trial Pharmacist
Xendo Drug Development, Groningen
- Management of Pharmacy section of Clinical Pharmacology Unit
- Responsible for all aspects of production and accountability of investigational medicinal products and other drug products used during clinical studies
- Implementation of new techniques within pharmacy section
- Release of drug products for clinical use (Qualified Person)
2002–2004 Manager Medical Department
Bional Holding, Gorredijk
- Management of Medical Department, responsible for Research & Development, Regulatory Affairs, Quality Assurance, and Training & Education divisions.
- Responsible for quality system and regulatory submissions
- Release of drug products (Qualified Person) and phytotherapy products (Food law)
1997–2002 Pharmacist
- management of public pharmacy
- responsible for all processes and distribution of drugs
- responsible for quality system
- accompanying daily recipe pace in public pharmacy
- design and implementation of Pharmaceutical Care projects
EDUCATION
1984 – 1990 Atheneum CSA te Aalten
1990 – 1995 Rijks Universiteit Groningen - Farmacie
1995 – 1997 RUG Groningen - Apothekersopleiding
SKILLS & COMPETENCES
Process Improvement, Strategic Planning,
Verbal & Written Communication, Attention to Detail, Thoroughness, Dealing with Complexity
GMP
GCP
GAMP5
Data Integrity
ISO 9001
ISO 15189
ISO 17025
ISO 7396
Lean Six Sigma
LANGUAGES
Dutch (native),
English (fluent),
German (good command)
PROFESSIONAL MEMBERSHIPS
Parenteral Drug Association (PDA)
International Society for Pharmaceutical Engineering (ISPE)
COURSES
2020GDP Responsible Person course (Farmatech)
2017Appreciative enquiry for compliance audits (Kerteza)
2015Education Lean Six Sigma Black Belt IBIS/UVA University of Amsterdam
2015Course ISO 17025 (Kerteza)
2013Masterclass NEN-EN-ISO 15189 (NEN-ISO/Kerteza)
2013Masterclass Medische Gassen NEN-EN-ISO 7396-1
2013Internal audit+ training for advanced auditors (V-KAM)
2012Training RvA/CCKL guidelines (Kerteza)
2012Course Train the GMP Trainer (DBA-NSF)
2010Course Human Failure Analysis Techniques (DBA-NSF)
2010Course Viral Safety for Biotechnologicals (Newlab)
2009PDA Workshop Monoclonal antibodies (PDA)
2008Statistics (DSM)
2008Course Drug Regulatory Affairs (RXN Regulatory Affairs)
2008Education BODL Module 4: “Biotechnology” at Delft University of Technology
2007Forum/Course Qualified Person (QP Association)
2006Course “GMP advanced” (Xendo Drug Development Services)
2005Course Process Analytical Technology (ISPE)
2005Course Good Clinical Practice (Xendo Drug Development Services)
2004Course GMP (Xendo Drug Development Services)
2004Course “Good Clinical Practice” (Groningen University Institute for Drug Exploration)
2003Course “GMP Middle Management” (PCS)
2002Course “Good Research Practices (GCP/GLP)” Rijks Universiteit Groningen
2000Management education for pharmacists (2 year education)
INVITED LECTURES AND TEACHING
2015Risk management for quality professionals at UMCG
2012-2018Hospital Pharmacy at University of Groningen regarding GMP
guidelines, quality management and medical gases
2011-2013Course Good Manufacturing Practice (Wenckebach)
2007-2012Several in-house lectures regarding quality and regulatory affairs
2002International Phytotherapy Conference at Lithuania
2002-2003Phytotherapie at University of Groningen