Job ID: 12137

CSV Expert (m/w/d)

Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.

Entourage. Stellenangebot.

Ort: Remote

Stellenart.

Project Consulting

Ihre Aufgaben.

  • Apply the Data Integrity regulations as described in Eudralex vol 4., FDA 21 CFR part 11, WHO annex 5 as well as the internal guidelines, SOPs, work instructions
  • Implement remediation activities in the context of the remediation plans 
  • Technical support in project planning of qualification/validation of computerized systems
  • Implementation of the systematic and efficient computer validation concept for the elimination of data integrity gaps
  • Contributing to the maintenance of the qualified condition of production equipment, testing equipment, computerized systems
  • Preparation/Adaption of qualification and CS validation documents
  • Documentation of the Q&V processes according to the GxP guidelines
  • Implement concepts once according to current data integrity requirements
  • Report to the project lead or deputy

Ihr Anforderungsprofil.

  • Completed pharmaceutical, scientific, or technical studies, preferably with a focus on computer science / EMR / automation technology or pharmaceutical technology / medical technology or comparable experience
  • Professional experience in pharmaceutical GMP environment
  • Professional experience in qualification/validation
  • Knowledge related to FDA and other regulatory requirements such as cGMP and MDD / ISO 13485
  • Profound knowledge in validation of computer-based systems
  • Language skills: German & English spoken and written

Vorteile.

  • Working remotely as much as possible
  • Working in an international environment and with state-of-the-art facilities at our clients facilities 
  • Attractive salary, corporate benefits and individual training opportunities

Gehalt.

Von: Keine Angabe
Bis: Keine Angabe

Region. Kategorie. Disziplin.

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