Michael Paar

Senior Consultant, GxPAssure

Michael Paar has been working in the pharmaceutical industry since 2007. From 2007 to 2019 he held various positions. Initially as Head of Quality Control and later as Director Quality Control as well as Director Quality Assurance/Operations and Qualified Person responsible for releasing active substances and medicinal products and maintaining QM systems.

Since 2015, he has been advising companies on various GxP-relevant issues and temporarily or permanently assumes the function as Qualified Person, head of QM/QA/QC, responsible person for pharmaceutical wholesale or as narcotics officer (BtM-V).

Michael Paar focuses on the establishment of QM- systems in the GxP environment, preparation, conduct, and follow-up of audits and inspections, training of employees and executives, as well as handling complex regulatory issues and communication with authorities.

The range of expertise includes chemical active substances and drugs as well as complex products (cell-based gene therapies, sterile drugs, DNA/RNA-based active substances) and products with special requirements (clinical trial supplies, medical cannabis and combination products)