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For 50 years, we've been driven by the firm belief that engineers are the architects of tomorrow's world, leading the way with their daring, their expertise and their ability to push boundaries.
Every day, our 5,000 employees innovate for our clients, partnering the world's greatest engineering projects in the fields of energy, healthcare, life sciences and transport.
A fast-growing international Group, we are present in 13 countries (in Europe, the Middle East, Asia and Africa).
Well known for our expertise in CQV (Commissioning Qualification Validation) and specialists in projects with strict technical and regulatory constraints, we partner pharmaceutical laboratories and high-tech industrial players to manage their capital expenditure and meet the challenges they face in terms of increasing safety and reducing costs and market lead times.
We innovate for our clients and provide them with disruptive technologies in the areas of data integrity, cybersecurity and predictive maintenance.
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.
- 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
At Assystem, everyone holds the reins for their own careers. Our role is to offer you the opportunities and resources you need to reach your full potential.
So why not join us and help shape the engineering landscape of the future?