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

expertum GmbH

Dortmund, Nordrhein-Westfalen, Deutschland
Published Oct 30, 2025
Full-time
No information

Job Summary

This role is ideal for a Quality Manager with expertise in GMP-regulated pharmaceutical environments, focusing heavily on hygiene and cleanroom operations. Day-to-day responsibilities include independently executing GMP-compliant hygiene and cleanroom monitoring, meticulously documenting and evaluating results, and coordinating external service providers such as cleaning companies and microbiological testing laboratories. The manager will also leverage their expertise to plan and lead hygiene and GMP training sessions for internal staff and external partners. A key focus is on quality assurance, involving the analysis of quality-relevant key figures, generating trending reports, and identifying optimization potential. The successful candidate will be proactive in handling deviations, managing Corrective and Preventive Actions (CAPAs), and supporting projects related to validation and process optimization, ensuring strict adherence to regulatory standards like EU-GMP Annex 1 and ISO 13485.

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 with hygiene processes, cleanroom technology, and hygiene monitoring
  • Professional experience in applying regulatory requirements (EU-GMP Annex 1, ISO 13485, 21 CFR 820)

Languages

German (Fluent)English (Basic)

Additional

  • Not specified