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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.
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
1. Perform investigation of customer complaints/quality defects
Coordination and performance of corrective and preventive action investigations (CAPAs)
- Batch Disposition:
Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and support production
1. Support and liaise with the Batch releasers responsible for product release
Responsible for reviewing production and batch records for completeness and releasing product
1. Perform quality review of orders prior to manufacture1. QA approval of environmental monitoring results and trends
Support the introduction of new products
1. Review and approve qualification/verification protocols/reports, procedures, specifications, validation deviations, and project validation/plans as required
Support the timely release of equipment, utilities, facilities, and computer systems following the execution of test protocols
1. Key member of Quality Risk Management and Operational Excellence to improve efficiencies and promote continuous improvement. Identify and implement continuous improvement opportunities
Ensure that change controls are aligned with applicable procedures and that they do not unintentionally alter the validated state of a process/product.
Ensure inspection readiness in work completed
1. Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring the site is always audit-ready. Maintain visibility on Production and Processing floors and perform spot checks on product and documentation
Assist in the internal and external audit program. Participation in regulatory and corporate/internal audits. Conduct audits as per internal audit schedule
1. Review and approve internal audit reports
- Documentation Management:
Manage and maintain the Documentation System
1. Review and approval of Quality documentation
- Quality System Management and Review:
Support completion of the Quality Management Review meetings and the Annual Product Quality Review
1. Ensure outcomes, decisions, and actions of the review are documented
Ensure meeting actions are completed to agreed deadlines
- Other:
Overview of regulatory/guidance and legislative updates relevant to Baxter
1. Compilation of reports in a timely manner as requested
Provide backup on control and issue of Quality Documentation
Review of process change controls
1. Training of Quality and Manufacturing personnel
Provide support in other Quality roles as needed
1. Compliance with Environmental Health & Safety (EHS) requirements
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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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.
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