GMP/GDP & Quality Systems
Quality Systems That Work – Not Just on Paper.
Practical senior support for GxP-compliant Quality Management Systems – from individual documents and processes to complex quality projects.
Your QMS needs to be compliant. But it also needs to work.
Quality systems can become complex quickly. Processes grow over time, responsibilities become unclear, documentation accumulates and operational teams struggle with systems that may be compliant on paper – but difficult to use in practice.
Sometimes the challenge is much simpler: your QA team simply doesn't have enough capacity to complete an important task.
That's where I can support you.
With more than 25 years of pharmaceutical and biotechnology experience, I provide hands-on support to develop, review, improve and maintain GxP-compliant Quality Management Systems.
How I Can Support Your Team
Quality Management Systems
Review, development and continuous improvement of GxP-compliant Quality Management Systems and processes.
SOPs & Documentation
Creation, review and optimization of SOPs, procedures and quality documentation.
Deviation & CAPA Management
Support with deviation processes, CAPAs and the development of clear, practical workflows.
Change Control
Support with the development, review and improvement of effective change-control processes.
Risk Management
Practical risk-based approaches for quality processes, projects and decision-making.
Document Management
Development and optimization of document-control structures, workflows and documentation processes.
Supplier Quality
Support with supplier qualification, Quality Agreements and supplier-quality processes.
Quality KPIs & Continuous Improvement
Development and improvement of meaningful quality metrics and processes to support efficient Quality Operations.
Sometimes You Don't Need a Consultant. You Need Someone Who Gets the Work Done.
I can support your existing team exactly where additional senior capacity is needed.
For example:
- reviewing or writing a set of SOPs
- clearing a documentation backlog
- improving an inefficient quality process
- supporting a specific Quality Systems project
- preparing documentation for an upcoming inspection
- reviewing an existing QMS process from an independent senior perspective
- providing temporary support during periods of increased workload
A few hours. A defined task. A complete project.
Quality Management From an Operational Perspective
I have spent more than 25 years working inside pharmaceutical and biotechnology organizations – not just advising them from the outside.
As Head of Quality Systems, my responsibilities have included the operational management and continuous improvement of GxP Quality Systems, including SOPs, training, Change Control, Deviations/CAPA, Risk Management, supplier management, Quality Agreements, document management and digital Quality Systems.
That experience allows me to combine regulatory requirements with a practical understanding of how Quality Systems need to function in everyday operations.