GMP Consulting

GMP, Audits, Medizinprodukte, MDR, Produktsicherheit, Validierungen, Biokompatibilität, Risikomanagement

• Audit / Inspektionen
• Gute Herstellungspraxis (GMP)
• Medizinprodukte

International manager in the pharmaceutical industry, Dr. rer. nat. with long-established experience in production, quality management, process ¬implementation and optimisation as well as in project management; head of manufacturing, safety officer for medical devices pursuant to Section 30 German Medical Devices Act (MPG); auditor



Excellent expertise in the pharmaceutical industry, in particular in all areas of aseptic filling of biotechnological APIs
Elaboration of optimum organisational and project structures and continuous alignment with corporate strategy and market requirements
Establishment of meaningful key indicator systems as the basis for deriving effective measures and ongoing monitoring of success
Ensuring of robust processes and standardisations, in particular in connection with GMP and regulatory requirements
Responsible for the smooth execution of client projects, from customer specification, feasibility study and offer calculation through to designing the production process
Initiation and control of complex national and international projects, from setting up an effective project structure through to successful implementation (e.g. production relocations)
Solution-oriented manager with an eye for the achievable
Experienced in the completion of international authority inspections and audits
Empathetic management style with excellent communication skills – internally, externally and at all hierarchical levels

GMP, MDR, Audit, Inspektionen, Validierungen