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.
Alongside auditing, I have supported pharmaceutical distributors and commercial affiliates continuously since 2019: GDP compliance, internal audits, procedures updated against GDP, pharmacovigilance and global corporate standards, and support during inspections by health authorities.
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. The person you brief is the person who arrives on site, writes the report and answers for it afterwards. No account manager between us, and no junior auditor sent in my place.
You set the deadline for the report. It is agreed before the audit starts, and I deliver to it.
Every finding is presented at the closing meeting, with the evidence and the requirement behind it. Your supplier knows where they stand before I leave the site, and nothing in the report that reaches you later is news to them. I audit the system, not the people running it. The point is a finding your supplier accepts and acts on, not one they spend a month disputing.
The audit does not end with the report. I answer your questions on the findings, review the CAPA plan, monitor implementation and close the audit.
Track record
Scope
Since 2019 I have 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: multinational corporations and Polish manufacturers, supplying markets inside and outside the EU. 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 went through inspections by Polish, Russian and other authorities, and 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 am still in the job, not only auditing it. I hold a Qualified Person role and certify batches, and I regularly take part in inspections by health authorities. I follow changes in the requirements because I have to apply them myself, not because a client is about to ask.
Five postgraduate programmes so far, between 2002 and 2024: quality management, microbiology, industrial pharmacy, a dedicated Qualified Person course and clinical trials. They are spread across two decades rather than sitting at the start of my career, because I took each one when the work called for it.
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.