Qualified Person · GMP, GDP and GVP auditor · Poland
I audit manufacturers, distributors and service providers on behalf of the companies that depend on them. More than 230 audits since 2019, in Europe, North and South America and Asia. I run the practice myself, so the person you brief is the person who arrives on site and writes the report.
Services
Two services, both delivered by one person. Audits are the larger part of the work.
Supplier qualification and requalification audits, for-cause audits after a complaint or an out of specification result, and gap assessments before an inspection. On site, remote or hybrid. Reports in English, delivered to a date agreed before the audit starts.
What an audit coversSetting up and maintaining quality management systems at manufacturers, importers and distributors of medicinal products and active substances, with a focus on quality control laboratories. Ongoing support, not a one off document.
How consulting worksApproach
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.
I audit against what a certifying Qualified Person has to be able to justify in front of an inspector, because I hold that role myself and certify batches for release.
Track record
Scope
Since 2019 I have audited suppliers across the whole supply chain.
EU GMP · EU GDP · EU GVP · ISO 9001 · ISO 17025 · ISO 13485 · ISO 15378
Clients
Manufacturers, marketing authorisation holders and distributors, in Poland and abroad.
Contact
Describe the site and the scope of the audit in a few sentences, and I will tell you whether I can take it and what it involves.