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Computerised Systems Validation - ERP/SAP validation

SME pharmaceutical manufacturer, Germany

Consultant, Coach

Overall project management as in-house project manager for an ERP project, complex interfaces in production environment and inventory control, sales management, monitoring deadlines and budget, establishing the internal organisation and the necessary hardware environment, optimisation phase, formulation of ERP specifications (URS), implementation of process WS, preparation of documentation, vendor selection and preparation of the ERP project, contract management

 

Chemicals company with pharmaceutical division, Germany / USA / France

Consultant, Coach

SAP project management (member of the project management team), SAP migration to ECC 6.0, project management and planning of measures, monitoring schedule and budget, building of a system map of the non-SAP applications for optimisation and validation testing, employee technical due diligence. Implementation of a proposed SAP validation, validation planning, specifications formulation (URS/FS), risk analysis, test management, change control, functional and integration test reports, validation report, preparation of life-cycle documentation, general consulting in SAP issues, merging of assets into a single company, SAP-to-SAP migration, project management and planning of measures, auditing of internal IT service provider (CSV, ISO etc. under GAMP5), monitoring of schedule and budget

 

SME Conglomerate with pharmaceutical division, Saudi Arabia

Consultant, Coach

Conduction of a proposed SAP validation ECC6.0, SOP harmonisation, validation planning, specifications formulation (URS/FS), risk analysis, test management, change control, functional and integration test reports, validation report, preparation of life-cycle documentation, consulting in general SAP questions

 

SME Pharmaceutical company, Turkey

Consultant, Coach

Conduction of a proposed SAP ECC6.0 validation / SOP harmonisation: Validation planning, specifications formulation (URS/FS), risk analysis, test management, change control, functional and integration test reports, validation report, preparation of life-cycle documentation

 

International pharmaceutical company, Austria

Consultant, Coach

Validation project manager of SAP revalidation as part of the implementation of the results of a mock inspection that was done in preparation of an FDA audit, formulation of validation planning, test management, change control, PQ and validation report, support of team in all CSV-related questions

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