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Quality Manager for Computerized System Validation

Quality Manager for Computerized System Validation

Informatik / Telekommunikation
  • Temporär - Vollzeit
  • Referenz : INT-039005
  • Teilen:

Einzelheiten

  • Region Zug
  • Art des Vertrags Temporär - Vollzeit
  • Tätigkeitssektor Informatik / Telekommunikation

Einführung

As a preferred supplier for Roche in Rotkreuz ZG, we are looking for an individual as

Quality Manager for Computerized System Validation

(contract until 31.12.2023 with possible extension). The earliest start date is within 1 month. Home Office: hybrid possible.

Aufgabenbeschreibung

• Act as an independent Quality Partner for our qualification & validation business teams (in particular for computerized system validation CSV)
• Enable our business partners to develop and execute compliant and efficient validation strategies based on our global quality management system
• Perform comprehensive and independent feedback, review and approval of all validation and qualification artifacts involved in the system life cycle
• Based on a deep understanding of our global quality management system: act as ambassador of the global quality assurance processes and thereby enable our business partners to deliver high class medical products
• Shape, live and defend our global quality management system


Erforderliches Profil

• Min. technical or scientific degree (FH/HF/University degree) or completed education in a technical profession (e.g. Computer Sciences, electrical engineering or IT) *****
• Min. 3-5 years practical expertise in the area of qualification and validation *****
• Experience in a GxP regulated environment *****
• Experience with quality management in the area of medical devices or in vitro Diagnostics (based on ISO 13485, FDA and Quality Systems Regulations) *****
• Fluency in English spoken and written
• German at least B1. Level (no certification needed)
• Pragmatically achieving highest quality standards while keeping stakeholders happy is your passion
• Good judgment, negotiation and communication skills, ability to prioritize tasks
• Autonomous, flexible, agile and open-minded team player with the ability to assert yourself

Nice to Have:

• Experience in the areas Artificial intelligence, Cloud solutions, Data integrity and CI/CD (continuous integration / continuous deployment) is considered a plus

Application process

Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application. Please upload your CV in English along with your degree certificate and latest reference letter.

Informationen

  • Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 19. Januar 2023
  • Berater-in Jie Zhu