Quality Assurance Manager for Qualification and Validation

Quality Assurance Manager for Qualification and Validation

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


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


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.


  • 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.


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