Menschen

Andreas Mannhart

Languages:

German, Mother Tongue English, written and spoken French, good knowledge written and spoken Italian: Basic knowledge

Attended Schools:

1975 - 1979 Elementary School Gotthelf, Basel 1979 - 1985 Math & Science High School, Basel 1985 - 1988 Business High School, Basel, Maturity Level 1988 – 1993 University HTL Bern, Master Engineering Informatics 1991 KV, Basel (Trade Diploma and Commercial Degree)

Diplomas Earned:

Master Diploma Engineering Informatics Trade Diploma and Commercial Degree Quality Manager and Auditor for ISO 9001:2000 Computer Systems Validation Expert on Annex 11, GAMP5 and 21CFR11 Certified IT Service Manager, ITIL, TüV Süd

Core Competencies:

+20 years Project- and Program Management • PM methods: Cobit, Hermes, Prince 2 • International fields for banks and the pharmaceutical industry • Experiences for migrations of more than 10’000 workstations and 1800 servers, requirements analysis, migration concepts and budget, team leading • Implementing large scaled projects within Enterprise Content Management Systems, • Document Management Systems and large Systems like SAP, eCTD and Documentum • Strong IT skills within IT Architecture, IT Infrastructure (Backend Network, Backend Storage and Virtualization) +17 years Quality Management • Validation Officer for Computerized Systems according Annex 11, GAMp5, 21 CFR11, ISO13485, ISO 62304 • Quality System within FDA (GxP), GAMP4 and PIC/S • Quality Systems within ISO 9001:2005 • Quality Systems within 13485:2012 • Risk Management according ISO 14971:2012 • Software Life Cycle Process according to IEC/EN 62304 • pecialization for Digital Signatures and Document Archiving / DMS • Specialization for the development of new Quality Management Systems • Specialization for improvement of existing Quality Management Systems +10 years Security Management • ISMS Conform Security Management according to ISO 27001, also Version 2022 • CISO Security Aspects and Architecture