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Quality Assurance Manager for Qualification and Validation

Quality Assurance Manager for Qualification and Validation

Chemie / Pharma / Biotechnologie
  • Temporär - Vollzeit
  • Referenz : INT-011793
  • Teilen:

Einzelheiten

  • Region Zug
  • Art des Vertrags Temporär - Vollzeit
  • Tätigkeitssektor Chemie / Pharma / Biotechnologie

Einführung

As a preferred supplier for Roche Switzerland in Rotkreuz, we are looking for a dedicated individual (f/m/d) as Quality Assurance Manager for Qualification and Validation (contract until the end of 2021 with the possibility to extend if suitable for all parties involved) Start date as soon as possible.

Aufgabenbeschreibung

  • Provide independently Quality process support for computerized system validation (CSV) helping business partners from Development and Operations to develop a compliant validation strategy based on system and functional risk assessment including security and data privacy requirements.
  • Provide independently Quality process support in the area of qualification & validation (equipment, process, analytical methods) and equipment management for your assigned business partner
  • Ensure sustainable compliance on site Rotkreuz Diagnostics International within area of responsibility (ISO 13485, FDA and Quality Systems Regulations)
  • Enable your business partner to conduct qualification and validation activities and to create the required documentation efficiently
  • Perform independent review and approval of process documents within area of responsibility (e.g. qualification plans & reports, equipment changes, all related documents to process / method / computerized system validation)
  • Identify opportunities for optimization of operational procedures in order to improve quality and efficiency within area of responsibility
  • Conduct training for Qualification & Validation processes and continuously monitor key performance indicators


Erforderliches Profil

Must haves:
  • Technical or scientific degree or completed education in a technical profession. 
  • At least 3 years of professional experience with quality management  preferably in relation to ISO 13485, FDA and Quality Systems Regulations.
  • At least 3 years of professional experience in governance of qualification and validation processes in the area of medical devices or in vitro Diagnostics 
  • Very good German language skills (B2 or higher) and good English verbal and written language skills
  • For supporting the business partners in the different areas experiences in production areas is a plus.
  • Good judgment & negotiation skills
  • Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator.

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.



Informationen

  • Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 20. April 2021
  • Berater-in Marijke van Engelenburg