Product Development Quality Assurance (PDQA) / Quality Engineer (QE), Fokus Bulk Drug Product (all genders) (Vollzeit, unbefristet)
Core
Support product quality assurance, drive process improvements, and contribute to quality systems for the manufacturing and testing of clinical trial materials, including imported products.
Role type
Quality Engineer (Pharmaceutical Manufacturing)
Builds
Clinical trial materials (Bulk Drug Products, APIs, intermediates) for oral, parenteral, and aseptic applications
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance knowledge, aseptic/non-aseptic manufacturing experience, deviation review, document management (SOPs, specifications), KPI tracking, process optimization
Preferred skills
Chemical engineering degree, SAP/OneTrack/LIMS experience, API/intermediate manufacturing background
Technologies
SAP, OneTrack, LIMS, TRACK, MS Office
Responsibilities
Support QP in release preparation for biological and chemical products; Review manufacturing instructions and analytical documents; Clarify deviations in documentation; Ensure GMP-compliant documentation practices; Participate in continuous process improvement initiatives; Develop efficient local processes and global best practices
Seniority
Mid-level, hands-on IC
