QA Expert (m/w/d)

Tasks :

• The Quality department is looking for a highly motivated Quality Assurance Expert to join the team dedicated to providing quality oversight for engineering and project activities related to Quality Control laboratory of biologic products.
• As QA Expert you will report directly to the QA Manager and be responsible for compliance and quality oversight and validation aspects related to laboratory projects.
• The QA Expert is the representative for both routine GMP (Good Manufacturing Practices) activities and project. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.
• Review and evaluate change requests according to procedures, GMP requirements and licenses
• Act as the Quality partner for QC Laboratory Projects
• Acts as Quality Representative facility projects to support the quality system deployment and application to meet the current Regulatory Requirements
• Execute guidelines and Regulatory cGMP requirements in the respective Quality area
• Responsible for quality aspects during the validation activities: review validation deliverables (i.e. validation plan, protocols, reports, URS, design qualification, risk assessment...),
• Define and challenge, validation approaches to be compliant with current regulations
• Lead and/or review deviations in the framework of events during the project (i.e., Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.
• Provide feedback on projects activities using proactive communicatio
• Prepare, evaluate, and approve controlled documentation revision.
• Report out of findings/issues to functional leaders and higher management as needed

Qualification:

• Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, ISO Quality system standards and data integrity principles
• Knowledge and interest in QC equipment/systems
• Knowledge in CSV and QC equipment/systems validation
• Background in QC GMP testing on biopharmaceutical products
• High affinity to digital technology
• Fluent in French
• Oral and written skills in English, fluency is an asset
• Education & Experience
• Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy or "Quality Management” applied to industrial process
• 3-5 years minimum of experience within a GMP environment, biotech/pharmaceutical company

Requirements:

Start : 19.05.2025