Quality Assurance Specialist

We are seeking a QA Specialist (C&Q) to support qualification and lifecycle management activities within a regulated manufacturing environment. The successful candidate will act as a key quality partner, ensuring systems remain compliant with regulatory requirements, industry standards, and company policies throughout their lifecycle.

Location: Beerse - 3 days on site and 2 days wfh

Start Date: 1st January 2027

Contract Length: 12 months

Language: English

Key Responsibilities

• Support change and project activities across the full system lifecycle, ensuring quality oversight throughout all qualification phases.
• Review and approve qualification documentation, including:
• User Requirements Specifications (URS)
• Risk Assessments
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ) protocols
• Test scripts and qualification reports
• Ensure all qualification activities comply with applicable regulations, industry guidelines, and internal quality standards.
• Review and approve procedures related to system qualification, calibration, maintenance, and lifecycle management.
• Assess, investigate, and support the resolution of system-related deviations, ensuring appropriate corrective and preventive actions (CAPAs) are implemented.
• Maintain up-to-date knowledge of regulatory requirements, industry best practices, and qualification standards, applying this knowledge to continuously improve processes.
• Provide support during regulatory inspections, customer audits, and internal compliance assessments, ensuring ongoing audit readiness.
• Partner with cross-functional teams involved in qualification and lifecycle management activities to ensure project objectives and timelines are achieved.

Candidate Profile

• Mid-level QA professional with experience in a regulated industry, preferably pharmaceutical, biotechnology, or medical device environments.
• Experience in qualification, validation, commissioning, or Quality Assurance is highly desirable.
• Strong understanding of quality systems, compliance requirements, and risk-based decision making.
• Excellent communication and stakeholder management skills.
• Ability to challenge constructively while building and maintaining positive working relationships.
• Proactive, detail-oriented, and comfortable working in a cross-functional environment.
• Demonstrates a strong quality and compliance mindset with a focus on continuous improvement.