A large global biotech manufacturing facility based in South Dublin is looking to expand their Compliance team on-site. This innovative company focuses on developing and manufacturing a diverse portfolio of drug products. They supply global markets from this facility. The planned growth is a result of the expansion of the site to maximise capabilities on-site.

The Role

The Compliance Specialist will:

• Be responsible for the Information Systems Compliance strategy for the site
• Support execution of IQ, OQ, PQ's on processes, equipment and systems in conjunction with site suppliers as appropriate
• Oversee and take ownership where required of NCs, CAPAs, Periodic Reviews and Quality metrics for the IS team
• Lead compliance activities for the IS Team
• Be accountable for implementation of processes and procedures related to IS compliance

The Person

The ideal candidate will have:

• Bachelors in Engineering, Computer Science or related Science discipline with 5-10 years' experience in Compliance of Information Systems or Quality Assurance in the biotechnology or pharmaceutical industries
• Understanding of Information Systems, principles of Automation
• Experience in cGMP regulated environments and in-depth knowledge
• Experience in change controls, non-conformance, corrective and preventative actions, and validation practices

To discover more about this opportunity, apply now or contact Ciara O'Brien at HRM on +353 1 632 18 55 for a confidential discussion.