Senior Computer System Validation (CSV) Expert

Selected references

CSV + CSA + project management

Oracle Argus Safety — workflow management system for adverse events management in drug safety (e.g. upgrades 3.x–8.x, over 1,200 global users)

Documentum — document management system

TrackWise — quality management system

PMX — production management system for the production and tracking of investigational drugs

System audits + supplier audits

Pharma Processes: Medical Affairs, Commercial Operations
IT Processes: Computer System Validation
Supplier Audits: Quality Management System, IT Quality

Some clients

Bayer Pharmaceuticals (since 2015 employed)
Bayer Business Services GmbH
Evonik Technochemie GmbH
Syncwork AG
IABG mbH
ARGUS Consult GmbH

Publications

Education and Training in the Field of Contaminated Sites:
A Project of the Ec-Comett-Program (Cb-Project)
Hentschel, A. / Schneider, G. (1993),
LINK »