Qualified Person Job at Baxter (Dublin)

Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. 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.

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
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
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
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
Batch Disposition
QA approval of environmental monitoring results and trends
Support the introduction of new products
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
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
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
Review and approve internal audit reports
Documentation Management
Quality System Management and Review
Support completion of the Quality Management Review meetings and the Annual Product Quality Review
Ensure outcomes, decisions, and actions of the review are documented
Ensure meeting actions are completed to agreed deadlines
Overview of regulatory/guidance and legislative updates relevant to Baxter
Compilation of reports in a timely manner as requested
Provide backup on control and issue of Quality Documentation
Review of process change controls
Training of Quality and Manufacturing personnel
Provide support in other Quality roles as needed

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
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

Nice to have

Experience/qualifications in microbiology/environmental monitoring a distinct advantage
Working in a project-based environment would be advantageous
Previous experience as a batch releaser would be advantageous

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Pension
Health Insurance
Life Assurance

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