QA C&Q Engineer

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

Imagine your next project as a QA C&Q professional where you will drive quality excellence in process equipment qualification activities and impact life-saving health innovations.

This role offers an exciting opportunity to join our team in Beerse as a QA C&Q professional, playing a key part in the review and approval of vital system lifecycle deliverables and ensuring high standards of compliance across various equipment qualification activities.

roles and responsibilities.

• 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.
• Participate in change projects throughout the entire system lifecycle. 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 that 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.

how to succeed.

• Medior QA professional with experience in a regulated environment. Demonstrated experience in qualification activities and the application of risk-based methodologies is preferred.
• Medior/senior qualification of process equipment for pharma (5+ years ideally, will consider medical device experience).
• Non-conformance investigation QA experience within qualification or equipment in manufacturing.
• Strong quality and compliance mindset.
• The ability to challenge constructively while maintaining a positive and productive relation with the stakeholders.

this role offers a very competitive hourly rate. This contract will run for 12 months

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

Diversity, Equity & Inclusion.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.