Quality Assurance Manager for Qualification und Validation 60-100% (m/f/d)

 

Quality Assurance Manager for Qualification und Validation 60-100% (m/f/d)

For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated Quality Assurance Manager for Qualification & Validation for one year with option for extension.

Tasks

  • 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

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

Are you interested? Do not hesitate and submit your complete application documents online today.

We value diversity and therefore welcome all applications – regardless of gender, social origin, religion/belief, age or identity.

We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!

  • Kontakt
    Andreas Zgraggen

    Arbeitsort
    Rotkreuz

    Anstellungsart
    Array

    Pensum
    60 – 100%

    Position
    Mitarbeiter




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