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