QA Aseptic Expert (Pharma)

Location: El Masnou, Spain; site-based role

Company

Global pharmaceutical CDMO founded in Switzerland, providing integrated development and manufacturing of active pharmaceutical ingredients and finished dosage forms across 16 sites.

What you will do

• Provide technical and strategic support for safe, timely, and compliant batch execution in manufacturing operations.
• Lead cross-functional aseptic governance and drive continuous improvement of aseptic practices and operational excellence.
• Lead the site’s Annual Aseptic Process Simulation program, including design, planning, execution, and documentation.
• Author and approve APS rationales, protocols, and reports while ensuring data integrity and technical robustness.
• Coordinate aseptic behavior monitoring during APS execution and collaborate with Manufacturing, Quality, and Maintenance.
• Lead aseptic-process investigations, root cause analysis, CAPA implementation, and effectiveness monitoring.

Requirements

• University degree in Biology, Pharmaceutical Technology, Chemistry, Pharmacy, or an equivalent scientific field.
• 3+ years of relevant experience in aseptic GMP manufacturing on the shop floor.
• Understanding of aseptic techniques, cell manufacturing, pharmaceutical GMP, and regulatory requirements.
• Previous GxP experience.
• Fluent English at least at First Certificate level.
• Excellent communication and collaboration skills.

Culture & Benefits

• Flexible working hours.
• Private health insurance.
• Life and accident insurance.
• Subsidized canteen.
• Pension plan.
• Collaborative environment with opportunities for professional growth.