Laboratory Metrology
il y a 7 jours
About the Role Join Excelya as a Laboratory Metrology & Qualification Specialist, where you will play a vital role in ensuring the accuracy and reliability of measurements across our laboratory operations. In this position, you will be responsible for developing, implementing, and maintaining measurement and qualification standards in alignment with regulatory requirements. The consultant will be responsible for ensuring the accuracy and reliability of metrology, verification, and qualification activities for laboratory instruments, equipment, utilities, and controlled environments. The mission covers both initial and periodic qualification phases, including technical validation according to operational and regulatory requirements (GMP and labor code standards). Main Responsibilities Health, Safety & Environment (HSE) Responsibilities: Apply and promote site HSE policies and procedures. Identify and report any hazardous situations, ensuring compliance with safety plans. Use personal protective equipment properly and ensure safety devices are not altered. Demonstrate exemplary safety behavior while encouraging safe practices among colleagues. Support continuous improvement in safety culture. Technical Responsibilities: Execute and ensure implementation of metrology and qualification processes according to internal procedures and regulatory requirements. Contribute to drafting and updating procedures, technical documentation, qualification protocols, and reports. Perform or supervise calibration, verification, qualification, and corrective interventions. Approve verification and calibration reports; review qualification reports if outsourced. Maintain compliance of metrology and qualification activities with laboratory and GMP expectations. Support investigations, deviations, technical troubleshooting, and associated CAPA management. Maintain and update databases related to equipment and qualification status. Manage reference standards, measurement devices, and related documentation. Coordinate service providers: planning, quotations, protocols, execution, reporting. Support equipment-related projects from a metrology/qualification perspective. Maintain KPIs and documentation ensuring traceability and performance follow-up. Contribute to audits, regulatory compliance monitoring, and continuous improvement initiatives. Requirements Experience: Proven experience in laboratory metrology and qualification processes, preferably in a pharmaceutical or biopharmaceutical environment. Skills: Strong understanding of metrology and qualification practices (equipment, utilities, controlled environments). Knowledge of GMP, laboratory operations, and qualification processes. Education: Engineering or scientific degree (BSc to MSc or equivalent). Languages: Proficient in English, both written and spoken; knowledge of additional languages is a plus. Benefits Why Join Us? We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid‑size CRO with the best employee experience. Our one‑stop provider service model—offering full service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside pre‑eminent experts, you will help improve scientific, operational, and humanknowledge to enhance the patient’s journey. Excelling with care 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. #J-18808-Ljbffr
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GMP Metrology
il y a 7 jours
Gidy, France Excelya Temps pleinA healthcare company is seeking a Laboratory Metrology & Qualification Specialist to ensure accurate measurements and compliance within laboratory operations. The role involves implementing and maintaining metrology standards, managing equipment calibration, and supporting investigations within a GMP environment. Ideal candidates will have experience in...