Senior QA CSV Consultant

I am a result driven, hands-on QA QMS Expert, with broad experience in general GxP & DI requirements, business analysis and Computer System Validation.

• 21 CFR Part 11
• Business Analysis
• Computer system validation (CSV)
• Data integrity
• GXP
• QMS
• Qualitätsmanagement / QS / QA (IT)
• Requirement Analyse
• Risk Assessment (FMEA)
• Technisches Qualitätsmanagement / QS / QA

Expert Knowledge on Eu GxP requirements, FDA 21 CFR Part 11, ISPE GAMP 5, MHRA, PDA TR84, PIC/S guidline, WHO guidlines for Computer Systems Validation and Data Integrity.
I have worked as a business analyst, gathering requirements and mapping the processes, performing risk analysis (FMEA) using critical thinking, writing functional specifications, user stories, acceptance criteria, test scripts, validation deliverable documents, defect/deviation reports.
I have extensive knowledge in systems used in the pharmaceutical industry such as SAP S/4 Hana QM, PM and WM, Trackwise, LIMS, MES, chromatography software, as well as the SDLC documentation and testing tools such as Solman, HP ALM, Proton, Adonis, Jira.