QA Specialist: Regulatory Compliance & System Qualification

MindCapture BV; Belgium; Remote; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Job summary

MindCapture BV is seeking a QA Specialist (C&Q) to support qualification activities and ensure compliance across the system lifecycle. You will review qualification documentation, oversee quality processes and contribute to continuous improvement while collaborating with stakeholders to meet regulatory requirements.

The role focuses on qualification documentation, change management, procedure review and audit readiness, with on-site work at client sites in Belgium.

Qualifications

• Medior level QA experience in a regulated environment.
• Strong understanding of quality requirements and applicable industry regulations.
• Experience in system qualification activities or QA with qualification processes is a plus.
• Ability to critically review technical documentation and qualification protocols.
• Understanding of deviation investigations, risk assessments and CAPA.

Responsibilities

• Review and approve qualification deliverables, including URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts and qualification reports.
• Participate in change projects across the system lifecycle ensuring compliance with regulations and quality standards.
• Review and approve procedures related to qualification, calibration, maintenance and lifecycle management.
• Assess and investigate deviations ensuring corrective and preventive actions (CAPA) are implemented.
• Maintain knowledge of international regulations and industry guidelines for system qualification.
• Identify opportunities to optimise qualification processes and strengthen compliance.
• Support regulatory inspections, audits and internal assessments with qualification expertise.

Skills

QA Experience

Regulatory Knowledge

Qualification Expertise

Documentation Skills

Deviation Management

Quality Mindset

Communication Skills

Constructive Challenge

Collaboration

Job description

MindCapture BV is seeking a QA Specialist (C&Q) to support qualification activities and ensure compliance across the system lifecycle. You will review qualification documentation, oversee quality processes and contribute to continuous improvement while collaborating with stakeholders to meet regulatory requirements.

The role focuses on qualification documentation, change management, procedure review and audit readiness, with on-site work at client sites in Belgium.