QC Systems Specialist (Change Control)

Summary:
Our client, a biopharmaceutical company based in Dublin, is looking for a QC Systems Specialist (Change Control). The ideal candidate will be involved in leading, coordinating, contributing to and undertaking activities pertaining to QC Change Control records. The incumbent will be responsible for owning and managing Change Controls through their life cycle for QC.

Responsibilities:

• Ensure timely completion of QC Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
• Ensure flow of communication to stakeholders.
• Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information.
• Monthly Metrics Management and Reporting.
• Participate in cross functional change controls.
• Contribute to success of QC Goals.
• Audit and Inspection preparation and participation.
• Lead continuous improvement activities to achieve standards of operational excellence for our client.
• Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals.
• Apply expertise and critical thinking to independently resolve issues.
• Provide technical guidance.
• Be responsible for specific programs and/or projects.

Qualifications & Experience:

• Hold a third level qualification in a Science related discipline.
• 4 or more years’ experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
• Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP
• Experience using Trackwise/Quality Management Tracking System (QMTS).
• Experience in managing and owning Change Controls would be advantageous.