Dr. Petra Lohmann, head of quality assurance

Since January 2020, Dr. Lohmann is head of quality assurance of RaDes GmbH. She studied chemistry as well as pharmaceutical sciences at the University of Münster and received her PhD in pharmaceutical chemistry. After working in analytics and quality control at Wyeth Pharma GmbH and Haupt Pharma GmbH, she joined Hermal GmbH in 2000, where she was head of quality control. In the R&D department she was qualified person (QP) as of 2005 and from 2013 to 2016 head of quality assurance. From 2016 to 2019 she was head of quality assurance at Bode Chemie GmbH (Hartmann Group), where she managed a portfolio of medical devices, pharmaceuticals, biocides and cosmetics.

As a result of these activities, she is thoroughly familiar with industry-relevant quality standards and regulations such as GMP, GCP, GLP, lSO 9001, ISO 13485, ISO 14001, AMG, AMWHV, 21 CFR 210/211, MDR and the requirements of pharmacopoeias, as well as with the evaluation and approval of qualifications and validations, the quality module of IMPDs and registration dossiers and the certification of clinical investigational medicinal products. Furthermore, she has extensive experience in planning and conducting internal and external audits and in designing delimitations of responsibilities in transfer and collaboration projects.

At RaDes, Dr. Lohmann is responsible for the establishment and maintenance of a quality management system as well as the quality standards for studies under GxP. She supports customer projects with strategies and expertise in quality and compliance aspects. In addition, she offers consulting and expert opinions in the field of quality management, e.g. GMP trainings, support in the preparation of inspections and advice on the establishment and optimization of quality management systems.