QA Compliance Expert – Permanent French part of Switzerland
We have an interesting opportunity for a QA expert who is interested in further development in biotechnology therapies in particular in biologics . This role will support QA and compliance operation for manufacturing of biologics for clinical trials
Your daily tasks:
• 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 activities such as equipment /system validation to meet defined agreements
• Review and update Validation Master Plan, system/equipment qualification
• Optimise facility quality processes based on EU/FDA GMP requirements and guidelines.
• Draft facility quality assurance policies and procedures and update quality manual
• Perform trainings for other team members in the Quality field
• Provide support to preparation for audits and inspection
• Support KPI preparation and reporting
EDUCATION AND DESIRED EXPERIENCE:
• Bachelor’s degree or equivalent in life sciences, engineering, biochemistry, biology pharmacy
• 5 Years of experience in GMP environment and hands ‘on experience in quality
• Experience in cleanroom engineering, Manufacturing, Computer validation system and system Qualification.
• Experience in deviation and change control management including CAPA system.
• Excellent Interpersonal and communication skills
• Highly organized and ability to work both independently as well as part of a team
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner
• Demonstrated skill in planning and organization, customer service, problem solving and proactivity
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.