Auditor, Blue Inspection Body GmbH

Norbert Waldöfner, PhD

 Norbert Waldöfner, PhD

Norbert Waldöfner has been working for blue inspection body GmbH, an ISO 17020 type A accredited service provider for GMP audits, since 2011. Since then, he has audited more than 200 companies worldwide, including manufacturers of starting materials and active ingredients for pharmaceutical products, as well as other suppliers and service providers (e.g. packaging manufacturers and logistics companies).

Prior to this, the doctor of chemistry worked in the development/production of sterile injection solutions for tumour therapy.

After studying chemistry at the University of Duisburg, he carried out his PhD at the Max Planck Institute for Coal Research (Mülheim a.d. Ruhr). He began his professional career at Magfore AG in Berlin, where he worked in the development/production of nanoparticles for medical applications and as head of the laboratory unit.

As Head of Operations at blue inspection body GmbH, Norbert Waldöfner is responsible for the quality of all audits performed. Together with his team, he ensures that the high quality requirements for GxP audits on the one hand and the accreditation requirements on the other are continuously met.

Furthermore, he is responsible for the qualification and training of auditors and is the company's quality management representative.

He is author or co-author of the following chapter of GMP Compliance Adviser:

  • 0.A.1 Information on nitrosamine impurities