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Summary 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. Sterile batch and patient‑specific products are manufactured in a clean room using LAF or CDSC technology.
The QP must complete training before applying to be a Qualified Person on the DCF Manufacturing Licence in Dublin.
Responsibilities Respond to pharmaceutical queries concerning compounded medicinal products from customers and Baxter’s home‑care nurses.
Support facility projects including process development and quality improvement initiatives.
Become eligible for inclusion on the Manufacturing Licence as a Qualified Person.
Ensure products and processes align with procedures and the principles of GMP.
Support and liaise with the batch releasers responsible for product release.
Support and liaise with dispatch and customer service to manage quality issues and timely customer service.
Prepare and support Deviation and QA trend reports.
Assist in developing critical metrics for performance evaluation.
Investigate customer complaints and quality defects.
Perform quality review of orders prior to manufacture.
Develop quality system procedures, controlled documents, and processes.
Review and investigate deviations, reject/scrap reports, and implement corrective and preventative actions.
Coordinate performance of corrective and preventive action investigations (CAPAs).
Review process change controls and validation protocols and reports.
Provide support to the site‑wide Quality Department.
Assist with the internal and external audit program, including regulatory and corporate/internal audits and supplier audits as required.
Perform recall assessment and supervision.
Train Quality and Manufacturing personnel.
Maintain professional status and standards.
Complete any other activities directed by Quality management.
Education and Experience 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 in a GMP‑regulated aseptic environment.
Experience/qualifications in microbiology/environmental monitoring is a distinct advantage.
Experience working in a project‑based environment is advantageous.
Experience implementing changes and process development.
Previous experience in an aseptic manufacturing facility.
Previous experience as a batch releaser is advantageous.
Skills Good problem‑solving and investigation skills.
Good professional standards, meticulous, 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 manage a wide range of specific tasks.
Good organizational, coordination, and communication skills.
Flexible.
Highly motivated.
Great teammate.
Benefits Competitive total compensation package.
Professional development opportunities.
High importance placed on work‑life balance.
Pension.
Health insurance.
Life assurance.
Equal Employment Opportunity Baxter is an equal‑opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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