Product Development Quality Assurance (PDQA) / Quality Engineer (QE), Fokus Bulk Drug Product (all genders) (Vollzeit, unbefristet)

📋 Description

• Support product quality assurance and process improvement in the manufacture and testing of
• Support the Qualified Person (QP) in the preparation of release of biological and chemical drug
• Review batch records, associated manufacturing protocols and analytical documents (e.g., test
• Review and clarify deviations in manufacturing and testing documentation; create or support the
• Ensure GMP-compliant documentation practices and monitor compliance of manufacturing and analytical
• Actively contribute to internal work planning and ensure timely completion of release activities.

🎯 Requirements

• Successfully completed vocational training as biology lab technician (Biolaborant), chemistry lab
• Several years of professional experience in quality control, manufacturing, technical or quality
• Solid MS Office skills; ideally additional experience with SAP, OneTrack, LIMS, and TRACK.
• Good knowledge of current GMP requirements; practical experience in aseptic and/or non-aseptic
• Understanding of agile environments, proactive approach, analytical and strategic thinking.
• Open and targeted communication – locally and globally – with strong teamwork and trusting

🎁 Benefits

• Diversity and inclusive work environment.
• Open corporate culture.
• Attractive compensation and benefits.
• Intense onboarding as well as professional and personal development.
• Flexible working models for a healthy work-life balance (hybrid: 3 days in office, 2 days remote).
• Health Management programs.