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
FAQs
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