Quality Manager Pharma (GxP) (w/m/d)
Festanstellung, Berufserfahren - TimișoaraWithin the Manage Now Governance organization, a dedicated quality unit is responsible to ensure compliance of Manage Now’s internal processes for IT service operations to the regulatory requirements. The person holding the position described in this document acts as IT Quality Assurance to ensure compliance to the beforementioned regulatory aspects locally. He or she actively works together with the Governance QM-Team to make sure the GxP-relevant processes are implemented, trained and followed locally. The person acts as SPOC and IT Subject Matter expert for all local staff regarding GxP-related activities.
- Single Point of Contact for all local GxP-related aspects in collaboration within the Quality Management 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
- Review of change requests focusing on risk assessments related to GxP-requirements including definition of required documentation
- Consulting of local staff regarding GxP-regulated processes (change management, infrastructure qualification activities, etc.) and tool-based processing.
- Collaboration with QM team to ensure local implementation of GxP-related processes. This includes providing feedback to QM team regarding local issues and proposals for improvement
- Review of validation and qualification documentation processed locally (e.g. IOQ test protocols, screenshots) from quality perspective
- Managing GxP relevant documentation (e.g. training records, process documents, templates)
- Supporting internal and external GxP-Audits as well as CAPA Management
▪ University degree in informatics, business engineering or equivalent
▪ Technical background in IT infrastructure
▪ Expert in Computer System Validation (CSV)
Required professional skills and experience
▪ 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 CSV, ideally qualification of IT infrastructure
▪ Familiar with CSV applications
▪ Knowledge in ISO 9001and ISO 20000
▪ Ideally knowledge in ISO 27001 and ISO 13485
Required personal skills
▪ High customer orientation
▪ Analytical thinking and structured working methods
Language skills
▪ Business fluent English in speaking and writing
▪ Ideally German language skills
Other - Mobility
▪ Occasionally traveling in Europe
ÜBER UNS
Manage Now ist ein führender IT-Service- und Managed Services Provider für Unternehmen und öffentliche Institutionen, die ihre IT strategisch weiterentwickeln und gleichzeitig stabil betreiben wollen. Mit über 50 Jahren kombinierter IT- und Projekterfahrung übernehmen wir Verantwortung für komplexe IT-Landschaften. Dabei verbinden wir Consulting, Betrieb und Transformation in einem integrierten Ansatz und schaffen so die Grundlage für eine IT, die zuverlässig funktioniert und gleichzeitig steuerbar bleibt. Unser integriertes Portfolio reicht von Sovereign Cloud und Hybrid- und Multi-Cloud über SAP und Application Management bis hin zu Security und modernen Arbeitsumgebungen und schafft die Grundlage für eine IT, die zuverlässig funktioniert und gleichzeitig steuerbar bleibt. Unternehmen entscheiden dabei selbst, wie viel Verantwortung sie abgeben wollen, vom einzelnen Service bis zur vollständigen End-to-End-Betriebsverantwortung.