Qualified Person, Baxter

Qualified Person

Baxter

Location:

Ireland, Dublin

Category:

Quality Control

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

The Qualified Person (QP) at the Baxter Healthcare Ltd Compounding Facility in Dublin is responsible for releasing Nutrition, Chemo, and Antibiotic products in accordance with regulatory standards. They provide oversight and quality assurance guidance for the compounding process, ensuring compliance with Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation, and Baxter Healthcare Ltd Standards.

Job Responsibility:

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 align with procedures and principles of GMP
Supporting and liaising with the Batch releasers responsible for product release
Supporting and liaising with Dispatch and customer service to manage quality issues and timely customer service
Supporting the preparation of Deviation and QA trend reports
Assisting in the development of critical metrics for performance evaluation
Supporting the investigation of customer complaints and 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 coordinating the performance of corrective and preventive action investigations (CAPAs)
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
Participation in regulatory and corporate/internal audits and performance of supplier audits (as required)
Performance and supervision of recall assessment
Participation in regulatory and corporate/internal audits and performance of supplier audits (as required)
Training of Quality and Manufacturing personnel
Compliance with Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
Maintenance of professional status and standards
To complete any other activities as directed by Quality management

Requirements:

QP Qualification
Pharmacy Degree (or equivalent experience) in a science-related field is required
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

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 Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:

March 21, 2025

Employment Type:

Fulltime

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