Projekt-Nr 28911-01
Berater GxP, ITIL, ISO, FDA (m/w)

Projektangebot für Freelancer
Position: IT Beratung / Consulting
Projekttyp: Freiberufliche Position (Freelancer)
 
Projektbeschreibung

Requirement profile / job description

Steering, consulting and operational support for IT infrastructure LifeCycle Management (IT infrastructure qualification strategy, ITIL service management, GxP @ Cloud and GxP on Premise) according to GxP regulatory requirements with the following know-how:


Language:

  • High level of written and spoken German and English

IT infrastructure:

  • ITIL Knowledge
  • Knowledge of the ITIL implementation at cusomer
  • Technical and strategic know-how of cloud solutions
  • Knowledge of IT infrastructure software (OS, ...), Core Tools (Inventory Solutions, Monitoring, Backup...) and Middleware (web services, databases)

Requirement for profile:

  • Academic education, preferably in a technical or (natural) scientific discipline
  • Excellent knowledge of the HealthCare regulatory requirements (FDA, EU, GxP, ISO 9001, ISO/IEC 27001) and best practices (GAMP5)
  • Experience in setting up IT quality management systems in the HealthCare environment
  • Experience in the implementation of IT infrastructure qualifications as a project manager
  • Excellent communicative and analytical skills
  • Pleasure in conceptual work and the development of innovative solutions

Activities to be carried out:

  • Consulting in implementation of GxP and Security @ Cloud
  • Steering and Controlling of Infrastructure Service Provider
  • Conception of qualification strategy and framework
  • Development of remediation plans, e.g. adaptation of risk-based qualification strategy to new regulatory requirements
  • Quality assurance in ITIL Service Management for IT-Infrastructure lifecycle
  • Creation and quality assurance of infrastructure qualification documents
  • Continuous improvement in quality of GxP environment
  • GxP-Compliance check of processes and documentation

Exclusion Criteria:

  • Less as you can see into the requirements profile

Einsatzorte: Remote und ab voraussichtlich Q4/20231


Stundensätze bitte Remote angeben. Reisekosten werden erstattet, sollte es zu vor Ort Einsätzen kommen

Anforderungen

Einsatzorte: Remote bis Ende Q3, ab Q4/2021 evtl. vor Ort


++++ (excellent), >4 yrs.
+++ (good), 2-4 yrs.
+++ (good), 2-4 yrs.
++ (trained), 0-2 yrs.
++ (trained), 0-2 yrs.

Geplanter Projektstart: 1.5.2021
Projektende: 30.6.2022
Einsatzort: Remote
Auslastung: 100%

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