Quality Control Specialist Functional Lead (m/w/d)
Core
Lead analytical processes and review test results in a GMP-regulated quality control laboratory.
Role type
Senior IC quality control specialist (functional lead)
Builds
Analytical test results and stability study data for pharmaceutical products
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
HPLC analytics, EMPOWER software, GMP/GxP compliance, analytical result evaluation, laboratory process coordination, stability study execution, qualification and validation support, equipment maintenance and calibration, supplier qualification, change management, KPI/KQI analysis, GMP documentation
Preferred skills
Experience in stability studies, qualification and validation activities
Technologies
HPLC, EMPOWER, MS Office, Lab information systems
Responsibilities
Review IPC and release analyses, plan and coordinate analytical workflows, provide technical support to lab staff, execute stability studies, support qualification and validation activities, ensure equipment maintenance and calibration, participate in supplier qualification and change management, monitor and analyze KPIs/KQIs, ensure GMP-compliant documentation
Seniority
Senior, hands-on IC
