QA C&Q Engineer - Process Equipment Validation Lead

Johnson & Johnson; Beerse; Sur place; EUR 83 000 - 110 000; Plein temps

Résumé du poste

Johnson & Johnson in Beerse is seeking a QA C&Q professional to lead risk-based qualification of process equipment and ensure compliance across the lifecycle. You will review URS, DQ/IQ/OQ/PQ, manage deviations, and support audits and inspections.

The role focuses on long-term quality excellence, collaborating with cross-functional teams, and ensuring alignment with international guidelines. This contract runs for 12 months and offers a competitive hourly rate.

Qualifications

• Medior QA professional with experience in a regulated environment.
• Experience in qualification activities and risk-based methodologies.
• 5+ years in qualification of process equipment for pharma (or medical device).
• Non-conformance investigation QA experience within qualification or equipment manufacturing.

Responsabilités

• Provide QA support for process equipment qualification activities, with a primary focus on the review of risk assessments to ensure that the appropriate risk assessment approach is applied and aligned with current quality principles.
• Review and approve qualification deliverables including User Requirements Specifications (URS), risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, qualification reports, to ensure compliance with applicable regulations, industry guidelines, and J&J policies and standards.
• Review and approve procedures related to qualification, calibration, maintenance and lifecycle management of systems.
• Ensure deviations related to systems (qualification, maintenance, calibration and/or use) with potential impact on quality and/or compliance are appropriately assessed, thoroughly investigated and effectively addressed through adequate corrective and preventive actions.
• Maintain a current understanding of applicable international regulations, guidelines and industry practices related to system qualification and apply this knowledge to continuously improve qualification processes.
• Support regulatory inspections, customer audits, and internal compliance assessments by ensuring audit readiness and providing subject matter expertise on qualification-related topics.
• Collaborate closely with cross-functional stakeholders involved in qualification and lifecycle management activities to ensure project timelines are achieved and organizational objectives are met.

Description du poste

Johnson & Johnson in Beerse is seeking a QA C&Q professional to lead risk-based qualification of process equipment and ensure compliance across the lifecycle. You will review URS, DQ/IQ/OQ/PQ, manage deviations, and support audits and inspections.

The role focuses on long-term quality excellence, collaborating with cross-functional teams, and ensuring alignment with international guidelines. This contract runs for 12 months and offers a competitive hourly rate.