Quality Managment, Software Testing and Validation

6/2023 – 6/2024

• Re-Validation of Lab/Q Lims
• Creation and conduction OQ Testcases
• Review of risk analyses and RTM
• Writing, review and translation of SOPs

Anforderungsspezifikationen, Change-Request-Management, Consultant, FMEA (Failure Mode and Effects Analysis), GXP, IT-Berater, Prozessvalidierung, Qualitätsdokumentation, Qualitätsmanagement / QS / QA (IT), Risikoanalyse, Testdesign (IT)

5/2019 – 6/2025

• Creating and Updating of documentation
• Extracting, transforming and loading biosample information
from various datascources in Biosample Information Management
System
• Design and implementation of upload procedures to Biobanking
Information Management System
• Design and organization of supporting master data in Biosample
Information Management System
• Testing of procedures and logic of Biosample Information
Management System to ensure proper excecution

2nd & 3rd Level Support, Anforderungsspezifikationen, Anwendungsadministration, Application Lifecycle Management, Business Analyst, Change-Request-Management, Consultant, FMEA (Failure Mode and Effects Analysis), Gute Laborpraxis (GLP), ISTQB, IT-Berater, It-Beratung, IT-Spezialist, ITIL, Manueller Tester IT-Qualitätssicherung, Projekt-Qualitätssicherung, Projektdurchführung, Projektorganisation, Projektplanung / -vorbereitung, Proof of Concept (POC), Qualitätsdokumentation, Qualitätshandbuch, Qualitätsmanagement / QS / QA (IT), Risikoanalyse, Testdesign (IT), Testen

1/2018 – 10/2018

• Design test strategy with reference to user requirements and functional
specifications
• Modular test approach
• Parameterized test approach
• consider risk assesment results for extent of test cases
• explore MES development environment
• author test scripts
• maintain change control
• review test scripts

Business Analyst, Change Management, FMEA (Failure Mode and Effects Analysis), Gute Laborpraxis (GLP), Manueller Tester IT-Qualitätssicherung, Qualitätsdokumentation, Qualitätsmanagement / QS / QA (IT), Test Management, Testdesign (IT), Testen