External Audits & Self-inspections

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/

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/