Aseptic Process Expert

hace 1 semana


Barcelona, España Siegfried A tiempo completo

We are looking for an Aseptic Process Expert to join our team, at our site based in El Masnou . ¿Quiere presentar una candidatura? Asegúrese de que su CV está actualizado y luego lea atentamente las siguientes especificaciones del puesto antes de solicitar. Reporting to the QA Operations Head, you will play a key role in ensuring the highest standards of sterility, quality, and operational excellence across our manufacturing processes. You will act as a technical reference for aseptic practices, driving continuous improvement and supporting cross-functional teams to maintain robust and compliant operations. In this role, you will: • Lead and actively participate in cross-functional aseptic governance, providing technical expertise and driving continuous improvement of aseptic behaviors across manufacturing operations. • Identify and implement process optimization opportunities to enhance operational excellence, product quality, and compliance with global standards. What will you do? • Serve as the primary technical point of contact for manufacturing operations, providing operational and strategic support to ensure safe, timely, and compliant batch execution. • Strengthen aseptic culture by developing technical competencies and guiding teams in unplanned or challenging situations. • Foster strong collaboration between Manufacturing, Quality, and Maintenance to maintain aseptic integrity and operational reliability. • Lead the site’s Aseptic Process Simulation (APS) strategy, including the design, planning, execution, and documentation of the Annual APS Program in alignment with GMP and regulatory expectations. • Author and approve APS rationales, protocols, and reports, ensuring data integrity and technical robustness. • Coordinate with QA to ensure proper monitoring of aseptic behaviors during APS execution across shifts. • Lead and support investigations related to aseptic processes, ensuring timely root cause analysis and effective CAPA implementation, while monitoring CAPA effectiveness through GMP systems. • Collaborate with global and local Quality teams to share learnings and ensure alignment with best aseptic practices. xcskxlj What are we looking for? • At least 3 years of previous experience managing aseptic processes • Previous experience managing aseptic process simulations • High level of English and Spanish What do we offer? • Working Hours: Flexible schedule, with start time between 7:30 and 9:30 a.m. and end time between 4:00 and 6:00 p.m. • Medical Insurance • Life and Accident Insurance • Subsidized Canteen • Pension Plan • Remote Work: One day week


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