Qualified Person – Pharmaceutical Manufacturing

About the role

The Qualified Person (QP) will be responsible for releasing nutrition, chemotherapy and antibiotic products at Baxter's Dublin compounding facility. Working in a clean‑room environment, the QP ensures that all sterile batch and patient‑specific products meet regulatory and company 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, develop controlled documents, and oversee corrective and preventive actions (CAPA).
• Participate in internal and external audits, supplier audits and recall assessments.

Required profile

• Completed training to act as a Qualified Person on the DCF Manufacturing Licence.
• Strong knowledge of Irish and European pharmaceutical legislation and GMP.
• Experience in sterile compounding and clean‑room operations (LAF or CDSC).
• Ability to work collaboratively with quality, production and regulatory teams.

Required skills

• Good Manufacturing Practice (GMP) compliance.
• CAPA (Corrective and Preventive Action) management.
• Validation protocol development and review.
• Laminar Air Flow (LAF) and Controlled Discharge Safety Cabinet (CDSC) technology.

What we offer

• Opportunity to work for a global healthcare leader.
• Continuous professional development and training.
• Collaborative and safety‑focused work environment.