Qualified Person – Pharmaceutical Manufacturing (Dublin)

About the role

The Qualified Person (QP) will oversee the release of nutrition, chemotherapy and antibiotic products at Baxter’s Dublin Compounding Facility. Working in a clean‑room environment, the QP ensures every batch complies with GMP, Irish and European legislation, and Baxter’s internal standards.

Key responsibilities

• Respond to pharmaceutical queries from customers and home‑care nurses.
• Support facility projects, process development and quality‑improvement initiatives.
• Maintain eligibility for inclusion on the Manufacturing Licence as a Qualified Person.
• Coordinate with batch releasers, dispatch and customer service to resolve quality issues.
• Prepare deviation and QA trend reports and develop critical performance metrics.
• Investigate customer complaints, quality defects and perform root‑cause analysis.
• Review orders prior to manufacture and develop controlled quality‑system documents.
• Lead corrective and preventive action (CAPA) investigations and manage validation protocols.
• Assist internal and external audits, including supplier audits and recall assessments.

Required profile

• Completed training to act as a Qualified Person on the DCF Manufacturing Licence.
• Strong knowledge of GMP, Irish and European pharmaceutical legislation.
• Experience in sterile batch and patient‑specific product manufacturing.
• Ability to work in a regulated clean‑room environment (LAF or CDSC technology).

Required skills

• Good Manufacturing Practice (GMP) compliance
• CAPA investigation and implementation
• Validation protocol development and review
• Batch release and quality assurance processes
• Regulatory compliance and documentation