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QA Aseptic Expert

On-site in El Masnou·Full-time·Added 1 month ago (last checked 23 Oct)

Siegfried

9 open roles

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Our summary

Work mode: On-site, El Masnou
Contract: Full-time
English: Required
Experience: 3+ years
Education: University degree
Benefits: Private health insurance

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Skills

This job advert was originally written in Spanish.

Requirements

What we're looking for

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.

Pay & benefits

What you'll get

Flexible working hours.
Private Health Insurance.
Life and Accident Insurance.
Subsidized Canteen.
Pension Plan.

The 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.

What you'll 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.

About Siegfried

In their own words

About the company & team

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and broad opportunities to demonstrate your talent. As a trusted and respected partner in the pharmaceutical industry, we maintain the highest standards in safety, quality, and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here you will find a workplace that values both collective success and your individual contributions, offering long-term opportunities to grow and make an impact.

Founded in 1873 in Zofingen, Switzerland, Siegfried has become a global network with 16 centers across three continents. With a team of more than 4,200 highly trained professionals, we bring our pharmaceutical clients' innovations to industrial scale and manufacture safe medicines for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations that can currently carry out the development and manufacture of active pharmaceutical ingredients (APIs) and finished dosage forms under one roof. This unique combination of knowledge and expertise makes us the most trusted partner in the pharmaceutical industry.