Beschreibung

For our client based in the canton of Berne, the Gi Life Sciences team is looking for :

Temporary contract

Qualification and Validation Specialist

Tasks :

  • Work closely with the Engineering and CQV teams
  • Ensure GMP compliant qualification activities
  • Participate in the assessment and management of problems in collaboration with other departments (Engineering and CVQ)
  • Participate in the continuous improvement of quality standards and problem management
  • Write validation protocols and reports
  • Review and approve C&Q/URS, RTM/QRA/IOC specific documentation as per standards
  • Review and assess project gaps if necessary

Profile :

  • Master's degree in biology, chemistry or equivalent
  • Minimum of 5 years' experience in qualification and validation in the pharmaceutical or biotechnology field
  • Experience in GMP, qualification, process validation and quality risk management
  • Commissioning experience on large scale projects
  • Fluent in English and German
  • The spirit of analysis and synthesis
  • Agility, flexibility and adaptability