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Quality Engineering Specialist.

Quality Engineering Specialist.

SwisslinxSwitzerland
Vor 30+ Tagen
Stellenbeschreibung

Your mission :

  • Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
  • Supports the development, reviews and releases qualification documents.
  • Approves applicable qualification documents
  • Assesses and approves change requests with regard to their relevance to the qualified state condition and ensures this supports and approves quality risk analysis (e.g. GMP-FMEA)
  • Ensures that deviations are appropriately investigated and addressed in deviation reports processed in deviation reports
  • QA activities follow legislation, authority and customer expectations.
  • Informs the Group Manager QA Qualification about relevant developments and trend
  • Actively supports the formulation and further development of qualification strategies and continues to training accordingly
  • Supports internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative (SME)

Your background :

  • Experience in biotechnology or pharmaceutical environment
  • Experience as QA Qualification
  • Knowledge on FAT / SAT / IQ / OQ / PQ
  • Experience in risk analysis is an advantage
  • Knowledge of SAP, DMS and TrackWise is an advantage
  • You are proactive, with good communication skills and are able to work in a multidisciplinary team towards a common goal.
  • You are fluent in English (spoken and written), German is an advantage

    • What's on offer

  • An initially 5 month contract.
  • A great opportunity to develop your career at a leading international biotechnology company.

    • If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter : .