- Dunboyne, Meath, Ireland
- Hybrid
- Full-time · Senior
Senior Quality IT & Data Integrity Specialist supporting biologics manufacturing operations
Responsibilities
- Provide quality oversight for Data Integrity and computerized systems across manufacturing and laboratory operations
- Lead and support Data Integrity-related deviations, investigations, root cause analysis and corrective and preventive actions
- Partner with system, process and data owners to ensure computerized systems meet business, quality and regulatory requirements
- Review and approve computerized system validation documentation, system changes, deviations and associated quality records
- Ensure computerized systems remain in a validated and compliant state throughout their lifecycle
Requirements
- Degree in Computer Science, Engineering, Life Sciences, Quality or a related discipline
- Nice to have: Biopharmaceutical Operations