משרות תוצאות חיפוש מתאימות לבקשתך:

How you’ll spend your day
•    Provide project validation and system life-cycle maintenance support by assisting the creation, reviewing and approving of all required validation deliverables from a GxP quality perspective.
•    Lead or support complex processes and new system implementations requiring a new perspective using existing solutions.
•    Resolve complex validation problems using existing solutions or applying new perspectives on existing solutions.
•    Actively contribute to extend and preserve the Computer Systems Validation (CSV) knowledge in the IT Q&C team and in the company.
•    Provide informal guidance to internal customers and team members as well as trainings when required (e.g. in project management, usage of policies, interpretation of regulations).
•    Work independently with minimal guidance.
 
Your experience and qualifications
•    At least five years of professional experience in complex CSV or SDLC activities in a GxP environment regulated by regulations like 21 CFR Part 11 and Eudralex Annex 11.
•    Validation experience with SAP ERP systems and a respective knowledge of the system’s processes.
•    Knowledge of risk-based validation approach, root cause analysis methodologies as well as Data Integrity (DI) principles.
•    Master’s or Bachelor’s degree