QA Aseptic Expert

"Expect to grow", personal y profesionalmente: En Siegfried, ofrecemos desafíos emocionantes y amplias oportunidades para demostrar tu talento. Como socio de confianza y respeto en la industria farmacéutica, mantenemos los más altos estándares en seguridad, calidad y sostenibilidad, mientras fomentamos una cultura que te empodera para prosperar. Únete a una empresa global en rápida expansión, donde diversas perspectivas y experiencias se unen en un entorno colaborativo. Aquí encontrarás un lugar de trabajo que valora tanto el éxito colectivo como tus contribuciones individuales, ofreciendo oportunidades a largo plazo para crecer y generar un impacto.

Your Role:  

Siegfried is looking for a QA Aseptic Expert to join our Quality Department at our El Masnou site.

As an Aseptic Process Expert, 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.

Key Responsibilities:

• 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.

Your Profile:

Education:

University degree in Biology, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.

Languages:

Fluent knowledge of English (at least First Certificate level)

Experience:

• 3+ years of relevant experience in aseptic GMP manufacturing shop floor is required.

• Proven understanding of aseptic techniques and cell manufacturing (Pharma, GMP, Regulatory aspects).

• Previous GxP experience is required.

• Excellent communication and collaboration skills.

Your Benefits: 

Our Benefits:

Fundada en 1873 en Zofingen, Suiza, Siegfried se ha convertido en una red global con 16 centros en tres continentes. Con un equipo de más de 4,200 profesionales altamente capacitados, llevamos las innovaciones de nuestros clientes farmacéuticos a escala industrial y fabricamos medicamentos seguros para pacientes de todo el mundo. Como CDMO totalmente integrada, Siegfried es una de las pocas organizaciones que actualmente puede llevar a cabo el desarrollo y la fabricación de ingredientes farmacéuticos activos (APIs) y formas farmacéuticas terminadas bajo un mismo techo. Esta combinación única de conocimientos y experiencia nos convierte en el socio más confiable de la industria farmacéutica.