Quality Assurance Expert

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Zusammenfassung

Lonza Stein is seeking an experienced QA professional to provide direct oversight of the Quality Control Microbiology team, ensuring GMP-compliant operations and ongoing improvement of cGMP processes on site.

You will drive the gLIMS implementation, review SOPs, manage deviations and changes, and support regulatory inspections with a pragmatic, data-driven approach. Fluency in English is required; German is preferred.

Qualifikationen

• 2+ years in gLIMS/LIMS within a regulated GMP environment.
• 7+ years in QA/QC role in pharma or biotech.
• Deep expertise in cGMP regulations and international pharmacopoeias (US/European/Japanese).
• Experience with equipment qualification, software validation, and data integrity standards.

Aufgaben

• Provide direct QA oversight to the Quality Control Microbiology department ensuring GMP compliance.
• Serve as QA lead for gLIMS implementation and related laboratory systems.
• Review and approve GMP documentation, SOP revisions, and gLIMS integration.
• Manage deviations (DRs), change controls (CRs), and document management activities.
• Oversee raw data review and support batch-related microbiology documentation release.
• Maintain and report departmental Quality KPIs to drive improvement.
• Support site readiness and represent QA during inspections and audits.

Kenntnisse

gLIMS/LIMS experience

QA/QC experience

cGMP knowledge

Regulatory audits

Lab data integrity

Software validation

Microbiology QC

English language

German preferred

Project management cert

Jobbeschreibung

Join our Quality Assurance team in Stein, supporting critical QC microbiology operations and driving the QA implementation of gLIMS for cutting-edge pharmaceutical manufacturing.

This role is primarily based on site. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.

What you will do:

• Provide direct QA oversight and technical guidance to the Quality Control Microbiology department to ensure full GMP compliance.
• Serve as the primary QA point of contact and subject matter expert for the implementation of gLIMS (Laboratory Information Management System) and laboratory execution systems.
• Review and approve GMP-relevant documentation, with a primary focus on SOP revisions and gLIMS integration.
• Manage and execute core quality compliance activities, including deviations (DRs), change controls (CRs), and document management.
• Oversee raw data review and support the review, approval, and release of batch-related microbiology documentation.
• Maintain and report departmental Quality KPIs to drive operational excellence and continuous improvement.
• Support site readiness and represent QA during health authority inspections and internal quality audits.

What we are looking for:

• 2+ years of experience in laboratory execution systems (gLIMS/LIMS) implementation within a regulated GMP environment.
• 7+ years in QA /QC role
• Deep expertise in cGMP regulations and international standards, including US, European, and Japanese Pharmacopoeia.
• Proven experience with laboratory equipment qualification, software validation, and data integrity standards.
• Strong background in QC microbiology processes, batch release procedures, and root-cause investigation tools.
• Demonstrated success interacting with health authorities (e.g., FDA, Swissmedic) during regulatory audits.
• Pragmatic, solution-oriented mindset with excellent organizational skills and a structured approach to problem-solving.
• Professional fluency in English, German language skills preferred and project management certification (e.g., Green/Black Belt) are strong advantages.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table.

At Lonza, we value diversity and are committed to creating an inclusive environment.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.

Ready to play your part in shaping the future of life sciences?