QA Microbiology & gLIMS Specialist (GMP)

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

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.