Qualification & Validation Specialist

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