Specialist Quality Assurance Technical Operations (m/w/d)
Core
Schnittstellenfunktion zwischen Qualitätssicherung und Supply Chain Management mit Fokus auf GMP-relevante Monitoringsysteme, Qualifizierungen und Temperatur-Mapping.
Role type
Specialist Quality Assurance Technical Operations
Builds
GMP-compliant monitoring systems and qualification documentation for supply chain storage areas
Domain
Pharmaceutical industry / Quality Assurance / Supply Chain
Deliverable
physical/clinical work
Required skills
GMP qualification processes, Risk analysis (FMEA, FTA, HACCP), Monitoring system administration, Temperature mapping studies, Regulatory compliance documentation
Preferred skills
Experience with Testo Saveris or Siemens Desigo CC, Experience in pharmaceutical or food industry, Engineering degree (Pharmaceutical, Chemical, Process Engineering)
Technologies
Testo Saveris, Siemens Desigo CC
Responsibilities
Configure and monitor GMP-relevant monitoring systems, Plan and execute storage area qualifications, Conduct temperature mapping studies, Perform risk analyses using FMEA/FTA/HACCP, Ensure regulatory compliance documentation
Seniority
Entry to Mid-level, hands-on specialist
