Global Compliance Consultant

I am economist and quality professional with focus on outcome that matters and expertise in project management, business processes as well as system validation/qualification principles.

• Business Analysis
• Compliance management
• Projektmanagement
• Risikomanagement

I am economist and quality professional with focus on outcome that matters and expertise in project management, business processes as well as system validation/qualification principles.

Extensive Consulting experience as IT-Controller, Validation Manager and Business Analyst on global projects spanning 40 countries with an investment in excess of $millions of dollars with in $50 billion Pharmaceutical company.

Experienced communicator in Polish, German, English, Mandarin & Korean. Leading GxP & non-GxP projects, worldwide, as a consultant in shortest time without defaulting on deadlines in terms of time, budget and quality.

HavesEdit International background, Ability to plan and organise on time, hands-on mentality, Ideas, Flexibility, University Degree in Management & Economics, Open-Source (R) Software, SharePoint, Oracle BPM, Salesforce.com, TrackWise, Validation of Computerized Systems, V-Model, waterfall model, IT-Compliance, pharmaceutical industry, SOX, GxP, FDA, EMEA, GAMP5, Quality Reviews, Validation Documents, Risk Management, Business Process Analysis & Modeling. Project Management, Quality Management, Validation Management, Qualification Management, Service Development, Test Management, Knowledge Management, Focus on Outcome that Matters