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.