Qualified Person Job at Baxter (Dublin)

Qualified Person

Baxter

Location:
Ireland , Dublin

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Licence awarded by the Health Products Regulatory Authority (HPRA). The Qualified Person (QP) is primarily responsible for release of Nutrition, Chemo and Antibiotic products. They should oversight and quality assurance expertise and guidance of the compounding process in line with regulatory standards. Sterile batch and patient specific products are manufactured using LAF or CDSC technology in a clean room environment.

Job Responsibility:

Release of Nutrition, Chemo and Antibiotic products
Oversight and quality assurance expertise and guidance of the compounding process
Ensure all products released comply with the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards
Responding to pharmaceutical queries concerning compounded medicinal products from customers and Baxter’s homecare nurses
Support facility projects including process development and quality improvement initiatives
Ensure products and processes comply with procedures and the principles of GMP
Supporting / Liaising with the Batch releasers responsible for product release
Supporting / Liaising with Dispatch and customer service to manage quality issues
Supporting the preparation of Deviation and QA trend reports
Supporting the preparation of Key Performance Indicators (KPIs)
Supporting investigation of customer complaints / quality defects
Perform quality review of orders prior to manufacture
Development of quality system procedures, controlled documents and processes
Review and investigation of deviations and reject / scrap reports and the implementation of corrective and preventative actions
Supporting and coordination and performance of corrective and preventive action investigations (CAPA’s)
Review of process change controls
Review of validation protocols and reports
Provide support to the site wide Quality Department
Assist in the internal and external audit program
Performance and supervision of recall assessment
Training of Quality and Manufacturing personnel
Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP)
Maintenance of professional status and standards

Requirements:

QP Qualification
Pharmacy Degree (or equivalent) in science-related discipline essential
Previous QP experience in a pharmaceutical company or equivalent-type role
Ideally a minimum of two years’ experience in a GMP regulated aseptic environment
Experience/qualifications in microbiology/environmental monitoring a distinct advantage
Working in a project-based environment would be advantageous
Experience of implementing changes and process development
Previous experience in an aseptic manufacturing facility
Previous experience as a batch releaser would be advantageous
Good problem solving and investigation skills
Good professional standards, meticulous and demonstrates good attention to detail
Ability to work under pressure and meet deadlines
Highly motivated self starter and team worker
Ability to work in a team based environment and ability to manage a wide range of specific tasks
Good organizational, coordination and communication skills
Flexible
Highly Motivated
Team Player

Nice to have:

Experience/qualifications in microbiology/environmental monitoring
Working in a project-based environment
Previous experience as a batch releaser

What we offer:

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 13, 2026

Baxter - All Job Offers

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