QA Engineer

QA Engineer #

(m/f/d)

Freelance project/fixed-term employment

Fribourg

Start date: immediately

Reference number: 890669/1

Missions ###

• Ensure GMP compliance of production and quality control activities
• Review, approve, and manage GMP documentation (batch records, SOPs, validation protocols and reports)
• Manage quality events (deviations, CAPA, change controls, investigations)
• Participate in the deployment, maintenance, and continuous improvement of the quality management system (QMS)
• Prepare, support, and follow up on internal audits, client audits, and health authority inspections
• Monitor quality indicators (KPIs), perform trend analyses, and recommend corrective or improvement actions
• Contribute to product quality reviews (PQR) as well as periodic evaluations of the quality system
• Guarantee data integrity and complete traceability of activities
• Provide quality support to operational teams and promote a quality culture within the organization

Profile ###

• Higher education in life sciences, pharmacy, chemistry, biotechnology, or an equivalent field
• Experience in Quality Assurance in a GMP environment
• Excellent knowledge of European GMP requirements, ICH guidelines, and regulatory authority expectations
• Proven experience in managing deviations, CAPA, change controls, and quality investigations
• Experience with internal audits, client audits, and regulatory inspections
• Good command of quality management systems (QMS) and continuous improvement processes
• Ability to review and approve complex GMP documentation with a high level of rigor and attention to detail
• Excellent communication skills and ability to collaborate with multidisciplinary teams
• Proficiency in French and English, both spoken and written

Benefits ###

• Join a recognized international company in the pharmaceutical sector.
• Develop in a demanding and stimulating GMP environment.
• Participate in various projects covering operational quality, quality systems, and regulatory compliance.