Autoren

Quality Manager Engineering

1981–1984 Training as Lab-Assistant at Behringwerke AG, Marburg (Germany)

1984–2010 additional trainings within Behringwerke AG, Marburg, InfraServ GmbH, Marburg, Aventis-Behring GmbH, Marburg, ZLB-Behring GmbH, Marburg and CSL-Behring GmbH, Marburg (Germany)
Qualifications:
Qualification Manager, Quality Manager,
Six-Sigma Project Manager, Auditor

1984–1990 Behringwerke AG Marburg (Germany), Lab Assistant, Sterile Manufacturing:
Organization and execution of environmental monitoring testing

1990–2000 Behringwerke AG / InfraServ GmbH Marburg (Germany), Deputy of head, Technical Process Assurance
Implementation of environmental monitoring programs
Implementation of equipment qualification programs
Implementation of pharmaceutical documentation system
Responsible for national and international inspections (FDA)

2000–2004 Aventis-Behring GmbH Marburg (Germany), Qualification Manager, Facility Qualification: Group leader with responsibility for qualification in the manufacturing areas “Sterile Manufacturing”, “Final Packaging” and “Production of blood plasma products”
Responsible for national and international inspections (FDA)

since 2004 ZLB-Behring GmbH / CSL-Behring GmbH Marburg (Germany), Quality Manager and Six-Sigma Project Manager
Technical deviation- and change-management
Training management
Technical submission management
Responsible for transport validation activities
Auditor for technical suppliers and service providers
Leader of improvement and Six-Sigma Projects
Responsible for national and international inspections (FDA)

since 2009 phaRmaK-Beratung UG, Ebsdorfergrund (Germany)
Managing Director
Service provider for pharmaceutical training and consulting

since 2001 Trainer for pharmaceutical technology, Berufsbildungszentrum Marburg (Germany)

since 2001 Member of committee for pharmaceutical technology, Industrie und Handelskammer Kassel (Germany)

since 2005 Trainer for pharmaceutical technology, Arbeitsgemeinschaft für pharmazeutische Verfahrenstechnik - APV, Mainz (Germany)

since 2006 Member of steering committee, national working group “Temperature Controlled Logistics” (Germany)

Publications at Maas & Peither GMP Publishing:

• GMP-MANUAL
  (Co-Author of GMP MANUAL chapter 18.H Questionnaire for preparing GMP-inspections)