Michał Krajewski

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 in seven pharmaceutical companies since then, multinational corporations and Polish manufacturers, supplying markets inside and outside the European Union.

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 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.

I work from Zgierz in central Poland, and I travel for most audits.