Autoren

Josef holds a Ph.D. in organic chemistry from the University of Zurich

1988-1989 Stanford University, CA (USA): Post-Doc (Civil Engineering Department); interdisciplinary research on the degradation of halogenated hydrocarbons in the soil.

1989-1995 Sandoz Pharma AG, Basel (Switzerland): Head of Laboratory in Analytical Research and Development; development and validation of methods, release analysis of APIs and dosage forms, clinical trial products, stability testing for registration, requests from authorities, dissolution rate testing, testing using micro HPLC.

1995-1998 Sandoz Pharma AG / since 1997 Novartis Pharma AG, Basel:
Product group head in the analytical control laboratory of Quality Assurance Pharma; responsible for Ciclosporin (API, up to 1996) and Sandimmun/Sandimmun Neoral (dosage forms); release analysis, stability testing, method validation, cleaning validation, process validation, complaints, requests from authorities, pharmacopoeia activities, competitor product analysis. After restructuring after merger to Novartis analytical responsibility for all peptide products (dosage forms); responsible for GMP training within the department.

1998 - 2000 CarboGen Laboratories (Aarau) AG, Switzerland: Head of Quality Control; responsible for installing adequate analytical and quality measures within Quality Control, GMP advisor

2000 - 2003 CarboGen Holding AG, Aarau: Chief Quality Officer; responsible for coordination, installation and expansion of the CarboGen Group with regard to all quality aspects.

2003 CarboGen AG: Head of Quality Management at Aarau Site; responsible for QA and QC

2003- 2007 Permamed AG: Qualified Person (QP) and Head of Quality Management; responsible for the whole quality section

since July 2007 Basilea Pharmaceutica International Ltd., Basel:
Quality Assurance, responsible for GMP training, guiding and supporting the affiliates in establishing the local QMS linked to the headquarters' QMS, QA/QC function for assigned development projects and marketed products. Since May 2009 Head of Quality Unit Technical Operations.

Cooperation in expert working groups

Regularly speaker at GMP training courses (since 1997)
Member of the Advisory Board of the GMP MANUAL
Member of the Advisory Board of the GMP-BERATER
As consultant member of the GMP Working Group of CEFIC/APIC (2001-2005)
- ICH Q7a - How To Do Document
- Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers - Integrating GMP (ICH Q7a) into ISO (9001:2000)

Publications at Maas & Peither GMP Publishing:

• GMP-MANUAL
  (Author of Chapter 14 Laboratory and Analytical Controls (Chapters 14.A Sampling to 14.I Raw data documentation) and Chapter 15.C.4 Testing procedures and test protocol)