Remote QA Qualification Engineer - Life Sciences

Amaris Consulting; Beerse; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting in Belgium is seeking a QA Qualification Engineer to support process equipment qualification activities, ensuring quality and regulatory compliance. You will collaborate with cross-functional teams and participate in change projects across the system lifecycle.

You will review qualification deliverables, maintain audit readiness, and contribute to continuous improvement of qualification processes while staying updated on international regulations and industry practices.

Qualifications

• Experience as a QA professional in a regulated environment.
• Experience in qualification activities and risk-based methodologies preferred.
• Strong quality and compliance mindset.
• Strong communication skills.
• Ability to challenge constructively while maintaining relationships with stakeholders.
• English fluent.

Responsabilités

• Provide QA support for process equipment qualification activities, focusing on risk assessments alignment with quality principles.
• Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, qualification reports) for compliance.
• Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems.
• Ensure deviations related to systems are assessed, investigated, and addressed via CAPA.
• Maintain awareness of international regulations and practices to improve qualification processes.
• Support regulatory inspections, customer audits, and internal assessments by ensuring audit readiness.

Connaissances

QA in regulated environment

Change management

Documentation review

Audit readiness

Cross-functional collaboration

English fluent

Description du poste

Amaris Consulting in Belgium is seeking a QA Qualification Engineer to support process equipment qualification activities, ensuring quality and regulatory compliance. You will collaborate with cross-functional teams and participate in change projects across the system lifecycle.

You will review qualification deliverables, maintain audit readiness, and contribute to continuous improvement of qualification processes while staying updated on international regulations and industry practices.