Chemgineering References / IS/IT Management / Computerised Systems Validation - CSV, 21CFR Part11, Annex 11/15 - general

Computerised Systems Validation - CSV, 21CFR Part11, Annex 11/15 - general

International pharmaceuticals/medical technology group, Germany

Consultant, Project Manager

Selection and implementation of an LIMS for worldwide branches, development of the validation strategy and planning

 

International pharmaceutical group, Switzerland

Consultant, Lead Auditor

Internal CSV-/IT audit of internal TrackWise development, lead auditor and CSV expert, reporting and corrector

 

International vitamin / pharmaceutical supplier, Switzerland / France

Consultant, Coach

Conduction of an assessment / project IT audit: Validation Status, SOP implementation status for all international branches, validation planning, specifications formulation, risk analysis, test management, change control, IQ, OQ, PQ report, validation report, preparation of an assessment report with proposals

 

International pharmaceutical supplier, Germany

Consultant, Coach

Conduction of an assessment/project IT audit of a SAP validation process and SAP QM third-party add-on software: Validation planning, specifications formulation, risk analysis, test management, change control, IQ, OQ, PQ report, validation report, preparation of a report with proposals

 

MES software producer, Germany

Consultant, Coach

Implementation of an IT/CSV assessment according to GAMP5 for product and project development

 

 

 

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