Qualified Person · GMP and GDP auditor · Poland
I audit pharmaceutical manufacturers, distributors and suppliers, and I run a licensed medicinal products manufacturing site covering quality control testing and batch certification. Over 230 audits since 2019, in Europe, North and South America and Asia.
What I do
I work through two businesses. The service you need decides which one.
Since 2019
External audits of GMP, GDP and ISO 9001, ISO 17025, ISO 13485 and ISO 15378 systems. Maintenance of quality management systems in manufacturing plants, wholesalers and sales and marketing organisations.
integrityphs.comSince 2020
A manufacturing site licensed for physicochemical testing in quality control of medicinal products and for batch certification of non-sterile human medicinal products. Method development, optimisation, validation and transfer. Stability studies, dissolution testing, particle size by air-jet sieving. Distribution of analytical reference standards.
scilo.euApproach
You work with me directly. I run the audit, I write the report, and I answer your questions about it afterwards.
You set the deadline for the report. It is agreed before the audit starts, and I deliver to it.
Engagements are not always single visits. Alongside auditing, I have supported one pharmaceutical distributor continuously since 2019: GDP compliance, internal audits, procedure updates against GDP, pharmacovigilance and the group's global standards, and support during inspections by the national medicines inspectorate at their wholesale site.
Track record
Scope
Between 2019 and 2026 I audited suppliers across the whole supply chain.
EU GMP · EU GDP · ISO 9001 · ISO 17025 · ISO 13485 · ISO 15378
About
I did not plan a career in quality. I studied process and environmental engineering, and in 2002 I started as a supervisor on the production floor of a pharmaceutical manufacturing site, writing departmental procedures and cleaning validation documentation, and working closely with the operators who ran the process. That is where I learned to look for the root cause of a problem instead of its symptoms.
Two years later I moved into quality assurance. I wrote a quality manual and risk management procedures, ran internal and external audits, and trained plant staff. I filled in what I was missing through postgraduate studies in quality management and microbiology.
In 2007 I became head of quality assurance, and in 2010 a Qualified Person. Batch certification changes your perspective. I have held that role for 16 years now, across six companies. In the same period I took part in introducing computerised systems for quality management and in an ERP implementation.
Between 2011 and 2018 I ran quality organisations of increasing size, ending with 115 people across two manufacturing plants and a pharmaceutical wholesaler. I took part in production and analytical transfers between Denmark, Norway and Poland. I sat through inspections by Polish, Russian and other authorities, and through customer audits from the receiving side of the table, which is the best training an auditor can get.
Auditing is the part of this work I have always enjoyed most. In 2019 I stopped managing and went back to auditing and consulting full time. I also run GMP training.
In 2020 I built a laboratory from zero and took it into a GMP regime. In June 2026 its manufacturing authorisation was extended to batch certification.
I completed three postgraduate programmes: industrial pharmacy, a dedicated Qualified Person course, and clinical trials. They broadened my perspective.
I work from Zgierz in central Poland, and I travel for most audits.
Credentials
"Non-conformities During GMP Audits", Świat Przemysłu Farmaceutycznego, issue 3/2024.
English fluent. German and French at reading and writing level.
Contact
Describe the project in a few sentences and I will tell you whether I can take it and what it involves.