- Process analysis and process optimisation
- Harmonisation and standardisation of systems and processes
over several sites globally
- Development and realisation of strategies and concepts for
rollout, operation and retirement of
GxP systems (Life Cycle
Management)
- Execution of risk analysis and implementation of the action
plan
-
FDA (21CFR11),
Annex11,
GAMP 4&5,
CSV
- Generation of specifications (URS,
FS and
DS) based on
business processes and user requirements
- Generation and implementation of test strategies and test
concepts
- Qualification / validation of IT systems, infrastructures
and applications (IQ,
OQ,
PQ /
UAT)
- Project leader (MES,
ERP, process management system)
- MES rollout (Honeywell, Werum)
- EBR &
MBR integration
- Writing of
SOPs
- Development of courses and training
- Line managerial responsibility < 70 FTEs (product management,
production, R&D, service, project teams and IT)
- Managerial responsibility in matrix organisation
- International and interdisciplinary collaboration
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