Key role: As a consultant, you will support our client to all their industrial project in quality assurance. As an Assurance Quality Expert, your role will be to ensure that the quality of product with the right regulation, such as GMP, client's expectation & MAA application. Key responsibilities - Ensure all quality regulatory & process are implemented, - Monitor quality in all department and ensure compliance with all regulation, * Review and validate all quality documentation with different department, - Monitor Change Control and review operational documentation link to the quality process, - Implementation and ensures adherence of appropriate regulations & quality standards and if needed, suggest improvement, - Provide support to the investigation process and follow-up to assure timely discrepancy closure, - Implementation and ensures adherence of appropriate regulations and quality standards, - Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), specifications, Batch Production Documents (BPDs) or Manufacturing Production Documents (MPDs), as needed, - Present systems and provide documentation for self-inspections and external audits, - Implement and ensures adherence of appropriate regulations and quality standards.
Assurance Quality Expert H/F
- Advanced technical degree (Master in Quality, in Pharmacist, Industrial Pharmacist...) in Bio- pharma or related fields.
- Experience of min. 5 years in the Biopharmaceutical / Life science industry in GMP environments in Quality Management according to FDA, Eudralex vol.4, ICH Q8/Q9/Q10, cGMPsarmacist...) in Bio- pharma or related fields
- Extensive experience in quality assurance, with dealing with CAPA, investigation, Change Control
- Good knowledge of quality management system
- Excellent knowledge of French and English