Quality Manager GMP Pharma & Cleanroom | Qualitätsmanager (m/w/d) GMP Pharma & Reinraum

expertum GmbH

Dortmund, Nordrhein-Westfalen, Deutschland
Published Dec 1, 2025
Full-time
No information

Job Summary

This role is for an experienced Quality Manager specializing in GMP-regulated pharmaceutical environments and cleanroom operations. Day-to-day responsibilities include independently conducting GMP-compliant hygiene and cleanroom monitoring, meticulously documenting and evaluating results, and coordinating external service providers for microbiological testing and cleaning. A key part of the job involves planning and leading hygiene and GMP training sessions for internal staff and external partners. The successful candidate will analyze quality-relevant key figures, generate trending reports, and identify optimization potential. They must be adept at handling deviations, processing CAPAs (Corrective and Preventive Actions), and supporting validation and process optimization projects. This position requires deep knowledge of regulatory requirements like EU-GMP Annex 1, ISO 13485, and 21 CFR 820, making it ideal for a professional committed to maintaining the highest quality standards in pharmaceutical manufacturing.

Required Skills

Education

Completed scientific-technical training (e.g., BTA, MTA, CTA, or Chemical Laboratory Technician)

Experience

  • Several years of experience in a GMP-regulated environment (Quality Assurance, Quality Control, or Production)
  • Professional experience in hygiene processes, cleanroom technology, and hygiene monitoring

Languages

German (Fluent)English (Intermediate)

Additional

  • Not specified