My Journey to GMP Compliance: From Lab Bench to Global Expert with a Dual Perspective
Every robust system has a story, and so does every expert. My journey in Good Manufacturing Practice (GMP) compliance spans more than 30 years, a path shaped by hands-on laboratory work, critical quality management roles, and a unique insight gained from experiencing audits from both sides of the table.
The Foundations: A Proactive Start in the Lab
My professional path in the GMP-regulated industry began in 1993, following my foundational training as a biological laboratory technician at Bayer AG. Those early years in microbiological quality control were immersive, focusing on the practical realities of sterile testing, microbial monitoring, and hygiene, which laid the groundwork for my comprehensive understanding of GMP requirements at the most fundamental level.
Crucially, my engagement with GMP wasn't just a job requirement; it started early and out of necessity. I became the GMP representative for my department when no one else was addressing GMP concerns. This proactive step demonstrated my commitment and deep understanding of quality standards, even before it became a widespread focus. This unique early experience shaped my approach to compliance – anticipating needs, implementing solutions, and driving quality from the ground up.
Evolution and Continuous Growth: Mastering Complexity
My commitment to continuous improvement has always been a core driving force. Throughout my career, I've actively pursued further training and development, constantly expanding my knowledge in areas like Project Management (including PRINCE2® Foundation, GDP, Six Sigma , and specialized software. This dedication ensures my expertise remains at the forefront of evolving industry standards.
Over the years, I evolved from a dedicated lab professional into a GMP Senior-Consultant and Quality Manager. My career path included significant roles and later as a Senior Consultant at gempex GmbH, a globally active service company supporting the chemical and pharmaceutical industry. These experiences provided me with a unique blend of scientific rigour, operational insight, and strategic quality management. My C2 Proficient English language skills have been instrumental in navigating complex international projects and communications, ensuring seamless collaboration across borders.
The Unique Advantage: Knowing Both Sides of the Audit Table
What truly sets me apart in the world of GMP compliance is this dual perspective. I don't just advise on audits; I've lived them from both angles:
As the Audited (Inspected Entity): For years, I served as a GMP representative in microbiological QC directly supervising inspections and audits by authorities. I understand the immense pressure, the internal complexities, and the challenge of proving compliance under scrutiny. I know how teams think and act when under inspection.
As the Auditor (Inspecting Party): As a 3rd-Party Auditor for gempex GmbH , I conducted numerous international audits in countries like Switzerland, Germany, France, India, and Canada. This experience has given me deep insights into the methodologies of auditors, what they look for, and how they assess compliance and risk. I understand how auditors think and act.
This dual insight means I offer pragmatic solutions that anticipate both auditor expectations and internal operational realities. I know what it takes to achieve compliance effectively and withstand rigorous scrutiny, because I've been on every side of that table.
Expertise in Action: Driving Compliance & Efficiency
My expertise spans the full spectrum of GMP and Quality Management Systems (QMS), covering diverse industries including pharmaceuticals, medical devices, cosmetics, cannabis (GACP), and logistics (GDP). Key areas of my hands-on expertise include:
Global LIMS & Digital Quality Systems: I have extensive experience in the implementation and optimization of complex digital systems, including a significant role as a QC expert in a global LIMS project in Berkeley, USA. I also have experience with digital quality systems for managing resources and the creation of Access databases for sample management.
QMS Implementation & Management: Setting up and managing comprehensive Quality Management Systems.
Documentation Excellence: Creating and optimizing core QMS documents like SOPs , Site Master Files (SMF) , Qualification and Validation Plans, and complete Quality Assurance (QA) System documentation. My work includes Good Documentation Practice (GDocP).
Deviation & CAPA Systems: Establishing and optimizing processes for handling deviations, complaints, and Corrective and Preventive Actions (CAPA). My work includes the introduction of electronic CAPA systems.
Qualification & Validation: Expertise in Qualifications and Validations , including equipment (e.g., implant production ), sterility testing isolators, and clean rooms (classes A-D ), and process validation.
Risk Management: Moderation and execution of risk analyses.
Training & Development: Creation and execution of numerous external trainings and presentations , including GMP training for employees.
Regulatory Strategy: Consulting on and implementing GMP regulations and guidelines (e.g., EU GMP-Guide , FDA-requirements , ISO 13485 ).
My C2 Proficient English language skills [1, 1] ensure seamless communication and effective project execution in international environments. My commitment is to translate complex regulatory requirements into clear, sustainable, and audit-ready solutions, ensuring your company's operational excellence and patient safety.
My Guiding Principles: Precision. Focus. Results.
My work is founded on core principles that define every engagement:
Precision: Rooted in Swiss standards and decades of meticulous work, every detail counts in compliance. My approach is characterized by thoroughness and accuracy.
Focus: Unlike larger firms that juggle multiple projects, I dedicate 100% of my attention to one client at a time, ensuring unparalleled commitment and efficiency.
Results: My goal is to deliver pragmatic, implementable solutions that not only achieve compliance but also improve your processes and provide measurable value.
Let's Discuss Your Compliance Journey
I believe in building strong partnerships based on trust and understanding. If you're looking for an expert who truly understands the intricacies of GMP compliance from every angle, I invite you to connect.
