QA Specialist: Trackwise, CAPA & cGMP Expert

Pauwels Consulting; Zwijnaarde; On-site; EUR 48,000 - 68,000; Full time

Job summary

Pauwels Consulting is seeking a Quality Assurance Specialist to support manufacturing and QC operations in a leading biotechnology organization. The role focuses on investigations, deviations, and continuous improvement to uphold high-quality standards in advanced therapies production.

You will join QC and manufacturing environments, drive CAPA management, change control, and Trackwise-based investigations, while ensuring cGMP compliance. Fluency in English is required, Dutch is a plus.

Qualifications

• Experience in quality assurance focusing on deviations and non-conformances.
• Knowledge of QC laboratory environments and cGMP standards.
• Experience with CAPA management and change control processes.
• Proficient in Trackwise and quality management software.
• Proactive and solution-oriented with ability to respond to urgent needs.
• Fluent in English.

Responsibilities

• Review and complete routine non-conformance and deviation investigations within manufacturing and QC environments.
• Conduct interviews with laboratory personnel to provide quality insights for Trackwise investigation reports.
• Collaborate with stakeholders to implement effective CAPAs and ensure timely completion of corrective actions.
• Propose and execute process improvements through the change management system.
• Monitor and report metrics on non-conformance investigations and quality performance.
• Maintain strict adherence to safety policies, quality systems, and cGMP requirements.

Skills

Quality assurance

Deviations

Non-conformances

QC labs

cGMP

CAPA management

Change control

Trackwise

Solution oriented

English fluency

Tools

Trackwise

Job description

Pauwels Consulting is seeking a Quality Assurance Specialist to support manufacturing and QC operations in a leading biotechnology organization. The role focuses on investigations, deviations, and continuous improvement to uphold high-quality standards in advanced therapies production.

You will join QC and manufacturing environments, drive CAPA management, change control, and Trackwise-based investigations, while ensuring cGMP compliance. Fluency in English is required, Dutch is a plus.