Our team

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.

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.

Marco is our specialist in QC, inspection readiness and supplier qualification. As a long-standing leader of QA, compliance and QC organizations, he has an extremely broad knowledge in the field of GMP/GDP and also has many years of experience in intercultural communication with health authorities and suppliers worldwide. Furthermore, Marco is a certified manager for strategic implementation and organizational change management and successfully led the restructuring and realignment of quality organizations.

Due to her extensive professional experience in quality control, Brigitte has profound knowledge in the field of qualification and validation in the chemical / pharmaceutical and medical sector. In the field of documentation, Brigitte has a broad knowledge of the creation of SOPs, work instructions, deviations, CAPA and change management in the common software (e.g. TrackWise, LIMS) of the pharmaceutical industry. Through customer projects, knowledge in the area of PQR creation, environmental monitoring and qualifications of pharmaceutical plants could be acquired and substantiated.

Thomas ist unser Experte für Qualifizierung / Validierung und Arbeitssicherheit / Gesundheitsschutz. Er verfügt über exzellente Kenntnisse im Bereich thermische Qualifizierung (Räume, Transport, Equipment) und Monitoringsysteme (inkl. Qualifizierung). Vertiefte Kenntnisse konnte er sich Rund um den Aufbau und die Pflege von pharmazeutischen Qualitätsmanagementsystemen (z.B. Dokumenten-, Schulungs-, Lieferantenmanagement, Audits) sowie als fachtechnisch verantwortliche Person im Grosshandel erwerben.

Als Spezialist Arbeitssicherheit / Gesundheitsschutz und Sicherheitsbeauftragter konnte Thomas sich beim Aufbau und der Pflege von Sicherheitssystemen einen Namen machen.