GXP and Quality Manager

Fujitsu Ver Empresa

Não especificado
Licenciatura

Fujitsu operates IT Systems for customers from various industries. For specific industries, such as the pharmaceutical industry, specific compliance regulations have to be taken into account during transition / set up of IT systems, its operations until the end of its lifecycle (i.e. GxP-requirements).

Within the Fujitsu MIS organization in Central Europe, a dedicated quality unit is responsible to ensure compliance of Fujitsus’ internal processes for IT service operations to the regulatory requirements (EMEIA MIS BO QRMC CE QM). The person holding the position described in this document acts as Quality Manager Pharma in order to ensure compliance to the beforementioned regulatory aspects locally. He actively works together with the central QM-Team in order to make sure the GxP-relevant processes are implemented, trained and followed locally. He acts as SPOC and IT Subject Matter expert for all local staff regarding GxP-related activities.

Main responsibilities

  • 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

Education and formal qualification requirements

  • 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 the area of CSV, ideally qualification of IT infrastructure
  • Ideally knowledge in ISO 9001 and ISO 20000

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

(Please attach your CV in English detailing language skills and availability)

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