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IT Quality Assurance Manager (Pharma)
IT & E-Commerce
Our client is an information and technology company, offering a full range of technology products, solutions and services.
Single Point of Contact for all local GxP-related aspects in collaboration with the central MIS GxP QM team;
Execution of local GxP Trainings for staff working on GxP-regulated IT Systems / Services. Ensures that all staff working on GxP-regulated IT Systems / Services are trained adequately before execution;
Consulting of local staff regarding GxP-regulated processes (change management, infrastructure qualification activities, etc.);
Collaboration with central MIS GxP QM team in order to ensure local implementation of GxP-related processes. This includes providing feedback to central MIS GxP QM team regarding local issues and proposals for improvement;
Review of qualification documentation processed locally (e.g. IOQ test protocols, screenshots) from quality perspective;
Managing qualification documentation (e.g. training records, IOQs, screenshots);
Supporting internal GxP-Audits.
University degree in Informatics, business engineering or equivalent
Technical Background in IT infrastructure
Expert in Computer System Validation (CSV)
3-5 years professional experience, working for IT Service Provider
Practical experience with validation / qualification of GxP-regulated IT Systems and its infrastructure, ideally in QA functions
Familiar with current GxP regulations in the area of CSV, ideally qualification of IT infrastructure
Ideally knowledge in ISO 9001 and ISO 20000
High customer orientation
Analytical thinking and structured working methods
Business fluent English in speaking and writing
Occasionally traveling in Europe
- Contract with the company;
- Competitive salary;
- Opportunity to join an expanding company.