לוח אפשרויות קריירה - הדרך החכמה להייטק

How you’ll spend your day
•    Provide project validation support by assisting the creation, reviewing and approving of all required validation deliverables from a GxP quality perspective.
•    Provide system life-cycle maintenance support by creating, reviewing, approving, and maintaining validation deliverables from a GxP quality perspective.
•    Support complex processes and new system implementations requiring a new perspective using existing solutions.
•    Resolve complex problems using existing solutions.
•    Apply innovative system validation or implementation approaches requiring a new perspective using 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 customers and team members when required (e.g. in project management, usage of policies, interpretation of regulations).
 
Your experience and qualifications
•    Degree in computer science, Information Technology or other relevant fields.
•    At least two years of professional experience in CSV or SDLC activities in a GxP regulated environment.
•    Experience in IT system implementation.
•    In-depth knowledge of GxP compliance requirements of the European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) and other international and national           GxP regulations and guidelines to validation & compliance (i.e. GAMP5, 21 CFR Part 11, Eudralex Annex 11).
•    Experience with and knowledge of processes in SAP ERP systems.
•    In-Depth working experience in Computer System Validation (CSV) in a regulated environment.
•    Knowledge of validation methodologies and Data Integrity (DI) principles.
•    A deep understanding of risk-based approach for validation and compliance activities.
•    Strong skills in applying and guiding others through root cause analysis techniques and CAPA definition.