QA Qualification Engineer

Pauwels Consulting; Beerse; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a QA Qualification Engineer for a leading pharmaceutical client in Belgium. You will oversee qualification activities for process and laboratory equipment to ensure compliance.

You will review URS, IQ, OQ, PQ, DQ and related reports, manage CAPA and change control, and support inspections and audits. Fluency in English and Dutch is required.

Qualifications

• 5+ years of QA experience in pharmaceutical or regulated environments.
• Expertise in qualification activities: IQ, OQ, PQ, URS, and equipment validation.
• Strong CAPA, deviation management and change control knowledge.
• Ability to challenge stakeholders constructively with a solution-oriented mindset.
• Fluent in English and Dutch.

Responsabilités

• Provide QA support for process equipment qualification activities and review risk assessments.
• Review and approve qualification deliverables: URS, DQ, IQ, OQ, PQ, test scripts, and qualification reports.
• Approve procedures related to qualification, calibration, maintenance, and lifecycle management.
• Assess deviations and implement CAPA.
• Support regulatory inspections and internal audits with SME on qualification topics.
• Manage change control projects and remediation for legacy systems.

Description du poste

Our client, a leading pharmaceutical organization, is seeking a QA Qualification Engineer to provide quality oversight for process and laboratory equipment. This role focuses on managing qualification activities throughout the system lifecycle to ensure strict compliance with international regulations and quality standards.

• Provide QA support for process equipment qualification activities and review risk assessments to ensure alignment with quality principles.
• Review and approve qualification deliverables including URS, DQ, IQ, OQ, PQ, test scripts, and qualification reports.
• Approve procedures related to the qualification, calibration, maintenance, and lifecycle management of systems.
• Assess and investigate deviations related to system qualification or maintenance and implement effective CAPA.
• Support regulatory inspections and internal audits by ensuring readiness and providing subject matter expertise on qualification topics.
• Manage change control projects and remediation activities for legacy systems across various departments.

• You have 5+ years of relevant experience in quality assurance within a pharmaceutical or regulated environment.
• You bring expertise in qualification activities, including IQ, OQ, PQ, URS, and equipment validation.
• You possess strong knowledge of CAPA, deviation management, and change control processes.
• You have a solution-oriented mindset with the ability to challenge stakeholders constructively.
• You are fluent in English and Dutch.

Nice to Haves

• Experience with sterile manufacturing and filter testing.
• Knowledge of remediation of legacy systems.