About Me
Professional GMP consultancy experience informed by both audit practice and operational responsibility in regulated environments.
About Me
I am a GMP consultant with more than 30 years of professional experience in regulated environments.
My work is rooted in long-term involvement with GMP systems, audits, and regulatory inspections — both from within regulated organizations and as an independent external auditor. Over time, this has shaped a pragmatic, documentation-focused approach to compliance that reflects how audits actually unfold in practice..
Professional Background
My professional career has developed across pharmaceutical manufacturing, medical devices, logistics (GDP), and GACP-regulated operations. I have held operational responsibilities, supported quality system implementation, and worked closely with regulatory authorities during inspections.
Rather than focusing on theory, my experience has been formed through direct involvement with day-to-day GMP realities: documentation, deviations, audit preparation, inspections, and corrective actions. This has created a clear understanding of how regulatory expectations translate into operational practice.
Dual Audit Perspective
A defining aspect of my work is experience from both sides of the audit process.
As an auditee, I have been responsible for preparing organizations for inspections and responding to regulatory findings.
As an external auditor, I conduct independent audits of quality systems, documentation, processes, and operational practices.
This dual perspective allows me to assess compliance not only against written requirements, but also against how systems are reviewed, questioned, and interpreted during audits.
How I work
My approach is structured, pragmatic, and documentation-focused.
I work with a strong emphasis on process optimization, clarity of responsibilities, and realistic implementation within regulated environments. My background in project management supports structured planning, execution, and follow-up of compliance-related initiatives.
I am a certified Six Sigma Yellow Belt and a PRINCE2® Project Manager, which informs a systematic, risk-aware, and results-oriented approach to GMP projects.
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Why Clients Work With Me
Clients typically contact me when they need:
- an independent and realistic assessment of their GMP status
- clear and defensible audit outcomes
- experienced third-party auditing support
- structured documentation and reporting
- calm and informed guidance in audit and inspection situations
My objective is not short-term compliance, but the development of quality systems that remain stable under regulatory scrutiny.
Training & Knowledge Transfer
Training is an important part of my work and is always grounded in practical audit and operational experience.
I provide training on GMP fundamentals, advanced compliance topics, inspection preparation, audit behavior, and data integrity. The objective is not only knowledge transfer, but practical understanding that can be applied in daily work.
All training sessions are available in English and German and may be supported by written reference material where appropriate.
Professional Exchange
If you would like to discuss your current GMP status, audit readiness, or a specific compliance topic, an initial professional exchange is possible.