At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. 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. #J-18808-Ljbffr
Baxter Healthcare in Dublin is seeking a Qualified Person (QP) to oversee and ensure compliance in the compounding of Nutrition, Chemo, and Antibiotic products. The candidate will handle pharmaceutical queries, liaise with various departments, and maintain operational quality. A Pharmacy degree and QP Qualification are essential, along with experience in a GMP-regulated environment. The role promotes a culture of collaboration and offers various professional development opportunities. #J-18808-Ljbffr
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Summary Lead facility & Equipment improvements by providing engineering expertise and project management for the maintenance and upgrade of infrastructure and systems that support compounding operations. Manage, arrange, and supervise equipment maintenance and upgrade efforts to ensure equipment availability, reliability, and capability are steadily enhanced. Essential duties and responsibilities Develop and put into practice preventative maintenance procedures and schedules that guarantee equipment availability, reliability, and product quality, in accordance with our business strategy and site requirements. Coordinate equipment and facility maintenance requirements with Quality and Operations to ensure compliance and minimize disruption to production schedules. Manage the contractor relationship for production support systems such as CPM and EMS. Apply the engineering upgrade plan for the Compounding Unit, concentrating significantly on reliability. Coordinate and manage the installation, testing, operation, maintenance, and repair of all facilities and equipment within the Compounding Unit. Develop and carry out preventative maintenance procedures and schedules that ensure equipment availability, reliability, and product quality in accordance with the Compounding Engineering Strategy and Baxter Perfect Equipment requirements. Direct and coordinate engineering activities associated with all Compounding units and equipment, managing contractors, service providers, installation engineers, etc. Manage and guide engineering projects connected to the Compounding Unit to guarantee timely and budget-conscious completion. Lead and support compounding capital, continuous improvement, and automation projects such as BAXA Repeater Pumps, working closely with SAN Project specialists and Unit Managers where required. Ensure planned, preventative, and reactive maintenance is performed per system requirements and on time. Support the procurement team as subject matter experts for facility systems (HVAC, Coldrooms, FMS etc.) in contract renewal and negotiations. Manage the relationship with outsourced vendors providing critical maintenance, calibration, and service contractors. Support and troubleshoot maintenance issues and system failures. Manage and support GMP documentation to complete validations and change controls for facility projects. Partner with local site EHS to ensure maintenance processes and capital projects are accomplished in compliance with applicable regulations. Identify and manage critical spares inventory for the Unit and liaise with other Compounding Units for parts sharing initiatives. Education and/or experience A solid amount of experience in maintaining electrical and mechanical plant and equipment. Experience in setting up new plant and equipment. Strong interpersonal skills and proficiency in conveying ideas. Responsive and flexible attitude to supporting internal and external customer requirements. Experience working in a support role with a strong emphasis on reliability. Rapid appreciation of issues, sound judgement, and problem-solving skills. Capacity to perform well when facing tight deadlines and remain effective while collaborating within a committed group. Flexibility to cover some weekend work or out-of-hour maintenance when required. At least 3 years' experience in efficient equipment upkeep and maintenance planning within the Pharmaceutical / Medical Device sector. Degree or equivalent experience in Science or a related field Demonstrated experience in a GDP/GMP setting, ideally with at least 2-3 years of background. Experience in dealing with regulatory compliance is desired. Skills Practical Problem Solving Project Management experience desired. Risk Assessment. Negotiation skills. Respond well to time constraints Good professional standards and demonstrates good attention to detail. Capability to perform effectively under pressure and achieve deadlines Highly motivated self-starter and team worker. Ability to collaborate within a group setting and handle a broad variety of distinct tasks. Strong organisational, coordination and communication abilities Ability to handle a wide variety of specific tasks. Excellent organisational and coordination skills Ability to work in a dynamic, fast-paced, and achievement-focused environment. Be determined. What are some of our benefits working at Baxter? 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. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review your Recruitment Fraud Notice. 88/89 Furze Road Sandyford Ind Est|Dublin|Co. Dublin|Ireland #J-18808-Ljbffr
