THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

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.

EDUCATION AND/OR 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’ 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

SKILLS

• 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 manage a wide range of specific tasks
• Good organizational, coordination, and communication skills
• Flexible
• Highly motivated
• Great Teammate
  What are some of the benefits of working at Baxter?
  We offer a competitive total compensation package, with professional development opportunities, where high importance is placed on work-life balance!
  Equal Opportunity Employer Statement: Baxter Healthcare Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
  Reasonable Accommodation Statement: Baxter Healthcare Corporation is committed to providing reasonable accommodations to applicants with disabilities. If you require a reasonable accommodation during the application process, please let us know.
  If the above resonates, or you would simply love to learn more about the role, apply today and we would be delighted to speak with you!
  We encourage you to apply today if you resonate with the above responsibilities and requirements.
  

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RESPONSIBILITIES

• 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
• Becoming eligible for inclusion on the Manufacturing License as a Qualified Person
• Ensure products and processes align with procedures and the 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

ESSENTIAL DUTIES AND RESPONSIBILITES

• Ensure compliance with cGMP, corporate standards/Baxter Quality Systems, site policies/procedures, regulatory requirements, and industry standards
• Maintaining awareness of Quality Management Review and Annual Product Review reports, relevant deviations, CAPAs, change controls, Regulatory Authority Inspections, and Product Complaints, and the use of unlicensed drug components
• Investigations:
  Participate in cross-functional teams as required to provide consultative support on quality-related issues. Provides support with investigations and resolution of discrepancies. Assures completeness in terms of root cause, action taken, and CAPA