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SUSUSONITY

Cleaning Validation Expert(m/w/x)

Aubonne
Full-timeOn-siteExperienced

Defining cleaning validation strategies for medicines and devices. MSc in Life Sciences or equivalent, with GMP/GDP knowledge required. On-site coordination and process development.

Requirements

  • MSc in Biotechnology, Life Sciences, or (Bio)Chemistry, or equivalent degree
  • Demonstrated experience in Cleaning validation
  • Strong analytical and synthesis capabilities
  • Excellent writing skills
  • Proficiency with GMP/GDP and health authority requirements
  • Organization, persistence, and resilience
  • Collaborative and independent work ability
  • Very good communication skills
  • Aptitude for digital tools
  • Fluent French and English (spoken and written)

Tasks

  • Define cleaning validation strategies
  • Collaborate with project lead and site departments
  • Identify risks and potential optimizations
  • Develop cleaning processes as needed
  • Coordinate on-site cleaning validations
  • Prepare required validation documents
  • Train production teams on validation protocols
  • Supervise validation protocol execution
  • Manage data collection from production
  • Interpret validation trial results
  • Manage deviations and investigations
  • Monitor cleaning processes
  • Draft monitoring forms and reports
  • Update validation procedures and standards
  • Ensure compliance with legal and regulatory requirements
  • Participate in a culture of integrity and ethics

Work Experience

  • 4 - 9 years

Education

  • Master's degree

Languages

  • FrenchFluent
  • EnglishFluent
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