Senior Expert Sterility Insurance

<p><strong>About the Job</strong></p><p>Join Excelya, where <strong>Audacity, Care, and Energy</strong> define who we are and how we work. As a Senior Expert in Sterility Insurance, you will take on a vital role in ensuring the integrity and safety of our sterilization processes within clinical development.</p><p>Your expertise will drive quality assurance in sterilization practices to comply with industry standards and regulatory requirements while fostering a culture of continuous improvement and excellence.</p><p></p><p><strong>Main Responsibilities:</strong></p><p>- Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)</p><p></p><p>- Communicating tasks to the project manager daily and via monthly KPIs. </p><p></p><p>- Tasks and deliverables for the project and authorities: </p><p>• Risk analyses (initiation, execution, conclusion, action plan) </p><p>• Drafting quality documents (test protocols/plans and reports, standard operating procedures, operating procedures) </p><p>• GAP analysis against GMP</p><p>• Scientific justification (documents) for deviations from regulatory requirements </p><p>• Monitoring action plans, investigations, and evaluation of out-of-specification (OOS) results </p><p>• Drafting the CCS DP</p><p><strong>Requirements</strong></p><p><strong>About You</strong></p><p>We're looking for an experienced professional who embodies our values and is committed to fostering excellence in sterilization processes.</p><ul> <li> <strong>Experience:</strong> Proven background in sterility assurance and risk management within the pharmaceutical or medical device industry (avoid requiring minimum years—<strong>talent matters most to us!</strong>)</li> <li> <strong>Skills:</strong> Deep understanding of regulatory compliance, sterilization methodologies, and GMP requirements; adept in investigations and CAPA management.</li> <li> <strong>Education:</strong> Bachelor's degree in a relevant scientific field; advanced degree preferred.</li> <li> <strong>Languages:</strong> Fluent in French and English; additional languages are a plus.</li> </ul><p><strong>Benefits</strong></p><p><strong>Why Join Us?</strong></p><p>At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.</p><p>Here’s what makes us unique—</p><p>We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s <strong>leading mid-size CRO </strong>with the <strong>best employee experience</strong>. Our <strong>one-stop provider service model</strong>—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.</p><p><strong>Excelling with care</strong> means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.</p>