QA Specialist – Pharmaceutical Manufacturing

About the role

This position offers a skilled QA Specialist the chance to join GE Healthcare’s manufacturing campus in Cork, supporting the production and global distribution of X‑ray and MRI contrast media. Reporting to the Value Stream Quality Leader, you will manage QA systems for a new high‑capacity filling line and ensure compliant batch release.

Key responsibilities

• Maintain compliance with GMP, GE Healthcare corporate standards, the Quality Management System, site policies, and regulatory requirements.
• Coordinate with customers and internal stakeholders to meet timelines and raise issues when needed.
• Lead cross‑functional continuous‑improvement initiatives and provide quality‑related consultancy.
• Investigate root causes, implement CAPA actions, and prevent recurrence.
• Author, review, approve, and manage documentation such as SOPs, investigations, change controls, validation records, and batch release files.
• Monitor and report on key site metrics to ensure ownership and compliance.

Required profile

• Degree in a Science or Engineering discipline or equivalent experience.
• Previous QA/QC experience in a GMP‑regulated pharmaceutical environment.
• Strong communication and interpersonal abilities, with capacity to work independently and within fast‑paced teams.

Required skills

• Good knowledge of GMP principles.
• Experience with Quality Management Systems (QMS).
• Capability to conduct CAPA investigations.
• Understanding of validation processes and batch release documentation.