Quality Control Technician

hace 1 semana

Sant Cugat del Vallès, España URIACH A tiempo completo

Job Title: Quality Control Technician Reports to : Quality Director Location: Sant Cugat del Vallès Employment Type : Full-time Mission:  Organize, control, and carry out finished product analyses, as well as stability studies, in accordance with the guidelines of the Quality Unit Manager. Participate in environmental declarations. Monitor that the specifications of finished products manufactured by third parties comply with the product registrations / technical data sheets. Follow up on Non-Conformities and corrective actions. Key Responsabilities:  Ensure and document compliance with all applicable quality and regulatory standards, including GMP/GDP for pharmaceuticals, ISO 13485 for Medical Devices, ISO 22716, ISO 22000, and internal Uriach CHC requirements. Draft, update, and maintain departmental SOPs (QA and ISO 14001–related), and review SOPs from other departments to ensure alignment with quality standards. Prepare, update, and manage finished product specifications in SAP QM according to regulatory dossiers and technical data sheets. Perform, supervise, and document analytical testing of finished products and stability studies, ensuring full adherence to regulated environments. Open, manage, and document Non-Conformities, define corrective and preventive actions, and communicate deviations to CMOs when necessary. Monitor Non-Conformity indicators and contribute to continuous improvement actions. Ensure proper custody, storage conditions, and overall control of batch samples within the sample library. Participate in feasibility and product development phases, defining pre-stability requirements and evaluating outcomes. Support internal and external audits, inspections, and requests from Health Authorities and Notified Bodies. Collaborate in the monitoring of the QA department's operating budget and the stability program budget. Provide technical and analytical information to internal teams including Supply, Innovation, CHC Regulatory Affairs, and CHC ROW. Manage and monitor stability studies for all products, ensuring accurate documentation and timely reporting. Prepare and submit environmental declarations (SIGRE, ECOEMBES, etc.) and ensure ongoing compliance with ISO 14001 environmental standards in Spain and Portugal. Maintain effective communication and collaboration with internal stakeholders (Demand Planner, Procurement, Innovation, Regulatory Affairs, CHC ROW) and external partners (CMOs, logistics operators, customers, Health Authorities, Notified Bodies, consultants, and external auditors). Sector: Industria Farmacéutica Función: Control de Calidad Higher Vocational Training (Grado Superior) in Analysis and Control.  Solid knowledge of SAP, especially the QM module. Proficiency in English (First Certificate level or equivalent). Strong IT skills, particularly in Microsoft Office tools. Knowledge of ISO standards (ISO 22000, ISO 13485), GMP guidelines, and quality regulations applicable to pharmaceutical or food environments. At least 2 years of experience in a Quality Control department within the Pharmaceutical or Food industry.

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