For our pharmaceutical client, localized in the French part of Switzerland, we are looking for a :
QA Facility Lead
Your mission
As part of the Quality Assurance and Compliance team, support quality and manufacturing organization.
Your responsibilities
- Responsible for the review of facility validation studies, facility SOP and environmental monitoring
- Responsible for the monitoring of facility relates audit findings, deviations change control and CAPA
- Execute Facility specific Quality assurance activities such as equipment /system validation to meet defined agreements
- Interpret reports results of work in both written and oral format including support on regulation application to employees
- Review and update Validation Master Plan, system/equipment qualification
- Optimize facility quality processes based on EU/FDA GMP requirements and guidelines.
- Draft facility quality assurance policies and procedures and update quality manual
- Perform training in facility Quality field
- Provide support to preparation and during on-site audits and inspections on documentation and on the floor elements
- Support KPI preparation and reporting
- Perform other relevant responsibilities as required
Your profile
- Bachelor degree in life sciences with at least 5 years' experience working in GMP environment and hands-on Quality
- Experience in cleanroom engineering, Manufacturing, Computer validation system and system Qualification
- Experience in deviation and change control management including CAPA system
- Fluency in English, both written and verbal is a must have, French is highly desirable
- This position may include domestic and international travels (up to 20%)
Your application
Please apply on-line. For more information, contact Ms Sophie Darthenay