QA

Overview
We are seeking a Quality Assurance contractor to support NC/CAPA and Change Control activities within a GMP‑regulated pharmaceutical manufacturing environment. This is a hands‑on role focused on day‑to‑day quality execution and operational support.

This is a 12‑month contract with a hybrid working model (3 days onsite in Beerse, 2 days remote). An ASAP start is important.

Key Responsibilities
NC / CAPA Management

• Own non‑conformances and deviations end‑to‑end
• Lead investigations and root cause analysis (e.g. 5 Whys, Fishbone)
• Define, implement, and track CAPAs to closure
• Ensure timely and compliant completion of quality events

Change Control

• Initiate and manage Change Controls within a GMP environment
• Perform GMP and quality impact assessments
• Coordinate inputs from Operations, Engineering, Validation, and other functions
• Ensure compliant implementation, verification, and closure of changes

Quality Operations

• Work within established quality systems and procedures
• Support audit readiness and respond to quality queries as required
• Prioritise and manage workload independently, particularly during initial onboarding

Required Experience & Skills

• Proven hands‑on experience managing NCs/Deviations and CAPAs end‑to‑end
• Practical Change Control execution experience in a pharmaceutical or biotech setting
• Solid understanding of GMP requirements and quality systems
• Experience using electronic QMS platforms (e.g. TrackWise or equivalent)
• Strong organisational skills and ability to work autonomously
• Clear and confident communication with cross‑functional stakeholders
• Fluent in English