Team

Anna-Myra Koopmans is a highly experienced GMP and sterile manufacturing professional with over 30 years of expertise in Quality Assurance, aseptic production and Qualified Person (QP) roles within the pharmaceutical and biotech industry. She is known for her decisive, results-driven approach and strong focus on inspection readiness and sustainable quality culture.

Since 2025, Anna-Myra has been working as an Independent GMP-QA Consultant, Trainer and Qualified Person at AMK Compliance Insight, supporting organizations with GMP compliance, sterile manufacturing, audit preparedness and strengthening Quality Culture. Prior to this, she served for nearly ten years as Director QA/QP at BioConnection, a CMO specialized in sterile products.

Expertise and services

• Sterile (aseptic) manufacturing – liquid and lyophilized products
• Contamination Control Strategy & Annex 1 compliance
• Aseptic Process Simulations (APS / media fills)
• GMP compliance, inspection readiness and audit preparation
• Internal and external audits & supplier qualification
• GMP training (QA, QP, CCS, sterile manufacturing)
• Qualified Person (QP) services for clinical and commercial products
• QA oversight of cleanroom and sterile equipment construction projects
• Quality culture and quality improvement projects
• Validation and qualification

Positions

• Independent GMP-QA Consultant / Trainer / QP – AMK Compliance Insight (2025–present)
• Director QA/QP – BioConnection B.V. (2016–2025)
• Qualified Person & Process Lead – MSD / Organon (2003–2016)
• Section Leader QA / Quality Systems – Organon
• Production Pharmacist – Organon (Parenteral & Special Products)
• Quality Officer & Validation Specialist – Organon

Education

• Pharmacist – Utrecht University

Skills

GMP • Sterile manufacturing • Qualified Person • Quality Assurance & Quality Systems • Annex 1 • APS / media fills • Inspection readiness • Audits • Validation • Quality Culture

LinkedIn

https://www.linkedin.com/in/anna-myra-koopmans-hoven-6716a720/

Astrid Bulsink is a senior consultant and project manager with over than 35 years of experience in quality management and process optimalisation within the pharmaceutical and (biotechnological) industry. She has extensive expertise in GMP and Quality Management Systems in regulated environments.

Since 2006, Astrid has been the owner of dArtis Consultancy, where she supports organisations in the design and optimisation of Quality Management Systems, project management, training and coaching. In addition, she works together with PCS as a Trainer, Consultant and Auditor.

Previously, Astrid held (international) managerial positions at, among others, Wyeth, Centocor, Chiron Corporation and HAL Allergy Group. 

Expertise and Services

• Quality Assurance and Quality Management (GMP)
• Pharmaceutical automation and laboratory systems
• Project management and process improvement
• Design and optimisation of Quality Management Systems
• Training and coaching
• Auditing

Positions

• Senior Consultant Pharmaceutical Quality Systems – dArtis Consultancy (2006–present)
• Trainer, Consultant & Auditor – PCS – Pharmaceutical Consultancy Services
• Director LACES Europe – Wyeth
• QA Manager / Project Manager – Centocor
• Quality Assurance Manager – Chiron Corporation
• Manager QC Laboratories – HAL Allergy Group

Education

• Bachelor of Science – Total Quality Management
• Molecular Sciences – Wageningen University

Skills

GMP • Quality Management Systems • Pharmaceutical Automation • Project Management • Training & Coaching • Auditing and Italian (B1/B2 level)

LinkedIn

https://www.linkedin.com/in/astrid-bulsink-7741b32b4/

Christine Mitchell is a highly experienced Quality Assurance professional and consultant with over 40 years of expertise in quality management and regulatory compliance within non-clinical and clinical safety assessment. She supports organizations in the design, improvement and maintenance of quality systems that comply with international GLP, GCP and GMP guidelines, with a strong focus on inspection readiness and sustainable compliance.

Since 2020, Christine has been Director and owner of ChrisalisQAdvice, where she works as an independent consultant providing advisory services, inspections, training and QA support in the field of quality systems and regulatory compliance within safety assessment and research environments. She has extensive experience in preparing for, hosting and supporting client and governmental inspections.

Expertise and services

• Design, implementation and optimization of QA and quality systems
• GLP, GCP and GMP compliance within non-clinical and clinical research
• Preparation, execution and follow-up of inspections and audits
• Training and knowledge transfer in quality management
• Computerised System Validation (CSV) and archive management

Positions

• Senior Director Regulatory Compliance / Head of Quality Assurance – Charles River Laboratories (2016–2019)
• Head of Quality Assurance – WIL Research, Den Bosch (2005–2016)
• Quality Assurance Manager – NOTOX (1985–2005)

Professional experience and involvement

Christine obtained her education in the United Kingdom and has provided QA and regulatory compliance support to organizations within the life sciences for more than 40 years. She has regularly presented at international conferences and participated in various OECD GLP expert working groups, including contributions to OECD GLP updates.

She is an active member of several professional QA networks and has previously held board and advisory roles within national and international quality organizations.

Professional memberships

• Former Chair – Dutch Association for Quality Assurance (DARQA)
• Member – DARQA GLP Committee
• Member – OECD GLP Industry Discussion Group
• Fellow member – UK Research Quality Association(RQA)
• Member – US Society of Quality Assurance (SQA)

Education

• BSc (Hons) Combined Studies – Chemistry & Biology (major in Toxicology), Leicester Polytechnic, UK

Skills

Quality Assurance • GLP • GCP • GMP • Regulatory compliance • Audits & inspections • Training • CSV • Quality systems development

LinkedIn

https://www.linkedin.com/in/christine-mitchell-17024a1a/

Eric van Wensveen is an experienced professional with over 40 years of experience in the pharmaceutical industry. He began his career in Research & Development and later served as the responsible Head of Quality for (radio)diagnostics and medicinal products, including membership of the management team. Eric specializes in EU and FDA GxP and has extensive experience with manufacturing and quality systems in an international context, supported by global export activities.

Since 2022, Eric has been the owner of the consultancy firm adQvice, where he supports organizations as a consultant, auditor, Qualified/Responsible Person (QP/RP), and trainer. He provides advisory services and delivers training in the areas of EU/FDA GMP compliance and manufacturing and quality management systems. Prior to this, he held senior positions at Curium and Mallinckrodt Pharmaceuticals, where he led the quality organization (50+ FTE) and was ultimately responsible for QA, QC, batch release, validation, and quality systems.

Expertise, Skills and Services
• EU & FDA GxP compliance
• Aseptic and terminally sterilized manufacturing (Annex 1)
• Quality systems (including Change Control, deviation and CAPA management)
• Quality Control and Sterility Assurance Management (including OOS/OOT)
• Batch release, Qualified Person (QP/RP)
• Validation and risk assessments
• Auditing
• Training and coaching
• (Quality) management

Professional Experience
• Director – adQvice (2022–present)
• Director Quality – Curium (2003–2022)
• Senior Project Leader R&D – Mallinckrodt Medical BV (1981–2003)
• Qualified Person (2006) / Responsible Person (GDP) (2014)

Education
• MSc Environmental Science / Management – Open Universiteit Nederland
• BSc Analytical Chemistry – Bakhuis Roozeboom Instituut
• Postgraduate program – Quality Management in Pharma/Biotech (LACDR / GUIDE / BODL / EUFEPS)

LinkedIn
https://www.linkedin.com/in/eric-van-wensveen-a077bb19/

Francis Buiter is an experienced trainer, consultant and Qualified Person with more than 15 years of experience in quality management within the pharmaceutical industry. She has extensive expertise in GMP and GDP and works at the intersection of Quality Assurance, batch release and training.

Since 2021, Francis has been active as a Trainer at PCS – Pharmaceutical Consultancy Services, where she delivers internal and external GxP training courses. In addition, she is the owner of Buiter Quality Solutions, where she works as a QA Consultant, Qualified Person and Responsible Person.

Francis is a certified NOBTRA trainer and specialises in developing and delivering GxP training programmes aimed at increasing GMP awareness and promoting quality-driven behaviour. In her role as a consultant from BQS, she works at Bilthoven Biologicals as a Senior Quality Assurance Specialist. Previously, she held the position of QA Operations Manager at Abbott Healthcare Products BV and Thermo Fisher Scientic, where she led an international QA team and a QA/QC/RA team.

She holds a degree in Pharmacy and is a qualified pharmacist, having graduated from the University of Groningen.

Expertise and Services

• GMP and GDP
• Quality Assurance
• Qualified Person (QP)
• Responsible Person (RP)
• GxP training and development
• Auditing
• Batch release
• Quality management systems
• Behavior- and culture-focused interventions

Positions

• Trainer – Pharmaceutical Consultancy Services (PCS) (2021–present)
• QA Consultant / Qualified Person / Responsible Person – Buiter Quality Solutions (2021–present)
• Senior Quality Assurance Specialist – Bilthoven Biologicals
• QA Operations Manager – Abbott Healthcare Products BV
• Quality Manager / Qualified Person – Thermo Fisher Scientific
• Consultant / Qualified Person – Xendo / ProPharma
• Qualified Person – Fort Dodge Animal Health

Education

• Pharmacy – University of Groningen

Skills

• GMP • GDP • Quality Assurance • Qualified Person (QP) • Responsible Person (RP) • GxP Training • Auditing • Batch Release • Quality Management Systems • Behavior- and culture-oriented interventions

LinkedIn:

https://www.linkedin.com/in/francis-buiter-rosenberg-05b25413/

Johan Hamminga is an experienced QA manager, consultant, trainer and auditor with more than 30 years of experience in quality assurance within the pharmaceutical and biotechnological industry. He has extensive expertise in GMP and GDP and broad experience with Quality Management Systems and regulatory inspections.

Since 2016, Johan has been active as Principal Consultant and Owner of Havem Pharma Consultancy, where he supports organisations with GMP and GDP compliance, preparation for and follow-up of regulatory inspections, CMC support, and the execution of audits and training. In addition, since 2021 he has been working with PCS as a Trainer and Consultant.

Previously, Johan held senior positions such as Director Quality Assurance at Allergan and Director Quality Assurance & Regulatory Affairs at Life Technologies. With his pragmatic approach, he supports organisations in improving quality and compliance within regulated environments.

Expertise and Services

• GMP and GDP
• Quality Management Systems (QMS)
• Regulatory inspections (preparation and follow-up)
• Responsible Person (RP)
• GMP and GDP audits
• GMP, GDP and Data Integrity training
• CMC support
• Project management

Positions

• Trainer & Auditor – PCS (2021–present)
• Principal Consultant / Owner – Havem Pharma Consultancy (2016–present)
• Consultant QMS & Responsible Person – Univar Solutions
• Head of QA Wholesale & Central Filling (a.i.) – Alliance Healthcare Netherlands
• QA Manager & Responsible Person – Brocacef
• Director Quality Assurance – Allergan
• Director Quality Assurance & Regulatory Affairs – Life Technologies
• Senior Project Manager / Compliance Manager – DSM Biologics

Education

• Bachelor of Science (BSc), Higher Laboratory Education (Immunology)
• Executive MBA – Nyenrode Business University

Skills

GMP • GDP • Quality Management Systems (QMS) • Regulatory Inspections • Responsible Person (RP) • Auditing • Training • CMC Support • Project Management

LinkedIn

https://www.linkedin.com/in/johanhamminga/

Jolanda Muurman is a highly experienced GMP professional, former Qualified Person (QP) and trainer with a strong background in biotechnological manufacturing, including upstream processing, downstream processing and aseptic manufacturing facilities. She supports organizations in the practical application of GMP principles within QA, manufacturing, qualification and validation, using a practical, accessible and hands-on training approach.

Since 2019, Jolanda has been the owner of Muurman QA & QP Services, where she works as a GMP trainer and freelance quality consultant. In addition, she has been Training & Development Manager at the Biotech Training Facility, where she was responsible for the development and organization of practice-oriented GMP training courses in a fully equipped biotech mock-up facility.
Currently, she supports small biotech start-ups in Switzerland, The Netherlands and Belgium as a consultant, with a focus on preparation for clinical manufacturing and IND/IMPD processes.

Expertise and services

• GMP training for biotech manufacturing
• Upstream & downstream processing
• Aseptic manufacturing facilities
• QA, QP roles, manufacturing, qualification and validation
• Development and organization of practice-oriented GMP training programs
• Application of GMP within CMC teams
• Support with IND/IMPD preparation

Positions

• Qualified Person / Quality Integrator – Janssen Infectious Disease & Vaccines 
• QA Officer / QA Consultant – OctoPlus, SynCo Bio Partners, Methnani & Associates
• Manager Manufacturing – Pharming Technologies BV
• Supplier Coordinator – Biogen Idec
• Quality Release Engineer – Merck Sharp & Dohme

Professional experience (selection)

Jolanda was trained as a (bio)process engineer at the University of Applied Sciences in Leeuwarden and the University of Greenwich (UK). She gained her in-depth knowledge of GMP and QP roles at several international (bio)pharmaceutical companies.

Within Janssen Vaccine Development, she fulfilled the role of Qualified Person and was involved in emergency vaccine supply activities during the Ebola outbreak in Africa in 2015. After this period, she started working as a freelance consultant in the GMP field.

In her current work, Jolanda combines consultancy and training, delivering courses on GMP, auditing, process validation, biotechnological processes and other pharmaceutical topics. She prefers working with smaller start-ups that are preparing for the manufacture of clinical trial materials and the associated regulatory submissions.

Education

• MSc in Management – University of Greenwich
• BSc in Biotechnology – NHL University of Applied Sciences

Skills

GMP • Biotech manufacturing • QA & QP • Training & development • Upstream & downstream processing • Aseptic manufacturing • Validation & qualification • Auditing • IND/IMPD support

LinkedIn

https://www.linkedin.com/in/jolanda-muurman-a868921/

Jolanda Tijmes is a senior consultant with over 20 years of experience in quality management within regulated environments, with a focus on Good Manufacturing Practice (GMP). She has extensive experience in QA and QC organizations and in managerial and advisory roles.

Since October 2019, Jolanda has been working with PCS as a Senior Consultant, where she supports organizations with auditing, change management, and quality issues. In addition, she has been active as an independent consultant through SusQiM since 2017.

Previously, she held various management positions at DSM, including QA Manager and Global QA Operations Manager. At Patheon, as Director of Quality Affairs, she was ultimately responsible for Quality Assurance and Quality Control and for the quality and safety of medicines under cGMP regulations. She has also worked in interim roles at FrieslandCampina and the Martini Hospital, among others.

Jolanda obtained her PhD from the University of Groningen.

Expertise and activities

• Good Manufacturing Practice (GMP)
• Quality Assurance and Quality Control
• Auditing (internal, external, and suppliers)
• Quality management systems
• Preparation and supervision of inspections and audits
• Change management within QA/QC organizations
• Interim QA and QESH management
• Team management and coaching
• Process improvement within regulated environments

Positions

• Senior Consultant – Pharmaceutical Consultancy Services (PCS) (2019–present)
• Independent Consultant / Owner – SusQiM (2017–present)
• QA/QC Manager – dsm-firmenich (2025–present, interim)
• Source & Systems QA Manager – FrieslandCampina (2024–2025, interim)
• Global Supplier Quality Manager – DSM (2023–2024)
• Global QA Operations Manager – DSM (2022–2023)
• QA Manager – DSM (2020–2022)
• Director Quality Affairs – Patheon (2013–2017)
• Various interim and management positions – DSM, CSK food enrichment, Martini Hospital

Education

• PhD Biotechnology – University of Groningen
• University degree in Chemistry – University of Groningen
• Higher Laboratory Education – analytical chemistry

Skills

GMP • Quality Assurance • Quality Control • Auditing • Quality Management Systems • Team Management • Coaching • Change Management • Process Improvement

LinkedIn:

https://www.linkedin.com/in/jolanda-tijmes-phd-0a48111b/