QC Senior Compliance Specialist

Your mission

As the QC Senior Compliance Specialist, you will be responsible for ensuring continued Good Manufacturing Practice (GMP)-compliant activities within QC to support the manufacture of gene therapy products. 

• Review and Approve QC documentation to support QC batch release.
• Generate, track and report on QC quality metrics.
• Drive quality improvement projects within the QC department.
• Support QC Managers/QC Team Leads in other activities where requested.

Job Description

Major Activities

• Review and approve Quality Control documentation ensureing timely release of GMP compliant product in accordance with product specifications promoting right first time initiative
• Coordination of stability records to ensure timely batch release
• Tracking and supporting of OOS Investigations to ensure timely closure
• Create, Track, trend and report QC KPI’s 
• To support the QC team with quality Investigations for timely closure if Quality events.
• Work closely with QC team leaders to ensure Quality Management documents (Change Requests, CAPA’s, Deviations) are completed within the given timelines
• Track and manage the documentation periodic reviews and ensure their completion in line with site procedures
• To generat