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Our team

Dirk Röhrig
PhD
Dirk Röhrig

Dirk is a very experienced former Swissmedic inspector specializing in GMP and GDP inspections of pharmaceutical manufacturing facilities and distribution systems. He also comes with broad experience in setting up robust pharmaceutical quality management systems according to cGMP, and in preparing and leading major health authority inspections in the pharmaceutical manufacturing setting. He has many years of consulting and project management experience, covering roles in interim management, as external qualified person, in supplier quality assurance, and in validation and qualification.


Michèle Roggwiller
Michèle Roggwiller

Prior to joining RQM GxP Consulting, Michèle most recently held the role of Enhanced Quality Program Site Lead for an API manufacturer, where she was responsible for establishing and describing manufacturing processes for products with enhanced quality requirements (ISO 9001). She comes with expert knowledge and broad experience in quality assurance, including validation according to ICH protocols, qualification, managing and adjudicating quality complaints, as well as the generation, review and improvements of standard operation procedures.


Michael Röhrig
PhD
Michael Röhrig

Michael is our specialist for qualification and validation. He was able to acquire in-depth knowledge especially in the field of CSV and thermal qualification (rooms, transport, sterilizers). He also has excellent experience in supplier qualification and supplier mangement (quality agreements, auditing, monitoring). As a quality responsible person (FvP) in the area of ​​manufacturing and wholesale, he was able to make a name for himself in the establishment and maintenance of pharmaceutical quality management systems.


Robin Brunner
Robin Brunner

Robin brings a very broad range of expertise in compliance management, document and training management. He has specialized in particular in the field of pharmacovigilance where he has made a name for himself as a Drug Safety Officer and PV responsible person at an international pharmaceutical organization. Furthermore, he has already been able to take on a number of mandates as a quality responsible person (FVP) in the area of ​​wholesale (without market release) with very positive customer feedback.
Expert knowledge in the qualification and validation of equipment and analytical method, as well as the optimization and continuous improvement of business and manufacturing processes round up his GxP profile.