QA Equipment Qualification Engineer — Healthcare

MindCapture; Belgique; Sur place; EUR 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture in Antwerp is hiring a Medior QA Equipment Qualification Engineer to join a GMP-regulated environment. You will oversee qualification activities for process and laboratory equipment, review qualification documents, support change controls and investigations, and help maintain inspection readiness.

Work with cross-functional partners to ensure compliant execution and timely project delivery, applying risk-based quality principles to equipment qualification, calibration, maintenance

Qualifications

• Experience with equipment qualification and risk-based methodologies.
• Pharmaceutical industry experience.
• Knowledge of GMP and regulatory guidelines.
• Strong focus on quality and practical problem-solving.

Responsabilités

• Provide QA oversight for equipment qualification activities.
• Review and approve user requirements, risk assessments, and qualification protocols.
• Lifecycle management of systems including calibration, maintenance and lifecycle processes.
• Assess deviations/non-conformances and support investigations with CAPA.
• Provide quality oversight for change projects throughout the system lifecycle.
• Ensure qualification activities meet applicable regulations and internal standards.
• Support regulatory inspections, customer audits and internal assessments.
• Maintain knowledge of regulations and best practices for qualification processes.
• Collaborate with cross-functional partners to achieve project objectives.
• Support remediation activities for legacy systems and qualification documentation.

Connaissances

Equipment qualification

Regulated environment

Quality mindset

Communication skills

English & Dutch

Formation

Pharmaceutical background

Description du poste

MindCapture in Antwerp is hiring a Medior QA Equipment Qualification Engineer to join a GMP-regulated environment. You will oversee qualification activities for process and laboratory equipment, review qualification documents, support change controls and investigations, and help maintain inspection readiness.

Work with cross-functional partners to ensure compliant execution and timely project delivery, applying risk-based quality principles to equipment qualification, calibration, maintenance