Aseptic Process Expert
hace 1 semana
We are looking for an Aseptic Process Expert to join our team, at our site based in El Masnou.
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.
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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