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Senior Quality Engineering Specialist

Senior Quality Engineering Specialist

LocationVisp, Switzerland
Business SectorBiotechnology
Contact nameDaria Finikova
Contact email
Job ref22895
Publishedabout 1 month ago
Key Responsibilities
  • Assesses and approves design documents (Facility Layout, Utilities Concept, Project Execution Concept)
  • Facilitates coordination meetings between different departments related to deliverables and activities in project initiation phase
  • Reviewing the layout and project execution plan against regulatory and company requirements
  • Assesses and approves User Requirement Specification/Technical Specification/P&IDs/Risk Assessments
  • Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
  • Actively supports the formulation and further development of qualification strategies for projects
  • Informs the Global Engineering Front End Group about relevant developments and trends
Key Requirements:
  • Experience in pharmaceutical GMP environment
  • Extensive experience in initiation, design, layout of assets for production of drug substance
  • Knowledge in regulatory requirements for facility design, layout, utilities
  • Knowledge in CAPEX project environment
  • 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)
Beneficial skills:
  • Experience in QA Qualification and Engineering
  • Experience in risk analysis
  • German speaking
  • Knowledge of Kneat
Practicalities:
  • 3 days onsite, 2 from home
  • Visp, Switzerland
  • 3 month project
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +41 4455 14407