Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your role:
We have an exciting Senior Validation Specialist position at our Irvine site. As a Validation Specialist, you will be responsible for performing all validation activities related to the Irvine site, both routine and project related. Your key responsibilities will include:Generate and ensure accuracy of validation protocols before execution.
Plan and coordinate the execution of validation protocols.
Collate and evaluate data from executed protocols; generate and approve summary reports.
Generate or approve Quality Risk Assessment documents related to validation activities.
Investigate and resolve deviations, raising CAPAs as necessary.
Participate in change control and risk evaluation activities related to validation.
Provide progress updates and reports to the Validation Supervisor.
Lead small multi-disciplinary teams as needed.
Interact with customers to understand and meet validation requirements.
Serve as a Subject Matter Expert during internal, customer, and regulatory audits.
Drive Continuous Improvement initiatives for product quality and regulatory compliance.
Engage in EHS activities, promoting safety and environmental awareness, and manage Risk Assessments.
Participate in Capital Expenditure initiatives as a validation subject matter expert.
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