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.

Your role at Baxter:

The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Licence awarded by the Health Products Regulatory Authority (HPRA). The Qualified Person (QP) is primarily responsible for release of Nutrition, Chemo and Antibiotic products. They should oversight and quality assurance expertise and guidance of the compounding process in line with regulatory standards.  Sterile batch and patient specific products are manufactured using isolator and/or LAF technology in a clean room environment.  It is the responsibility of the Qualified Person to ensure that all products released from the Dublin Compounding Facility comply with the Manufacturing Licence, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.

The Qualified Person (QP) is responsible for undertaking the necessary training prior to application for inclusion as a Qualified Person on the Dublin Compounding Facility (DCF) Manufacturing Licence.

What are your Responsibilities:

• 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.
• Perform investigation of customer complaints / quality defects
• Coordination and Performance of corrective and preventive action investigations (CAPA’s)

• Batch Disposition:

• Ensure that operational instructional documentation (SOPs and batch documentation) are up to date, compliant, and supports production.
• Liaising with the Batch releasers responsible for product release.
• Responsible for reviewing production and batch records for completeness and releasing product.
• Perform quality review of orders prior to manufacture
• Liaising with Dispatch and customer service to manage quality issues and timely customer service
• QA approval of environmental monitoring results and trends

• Merlin manufacturing system and Stability:
  • Maintenance of Merlin Component Files, Finished Product Codes and review of drug admixture stability and assignment of shelf-lives

• Facilitate, review, update and maintaining stability data on the system when required and in accordance to the annual stability review schedule.

• Changes/New projects/Periodic reviews:

• Support the introduction of new products
• To review and approve qualification/verification protocols/reports, procedures, specification, 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 to promote continuous improvement. Identify and implement continuous improvement opportunities.
• Ensure that change controls are compliant with applicable procedures and that it does not inadvertently alter the validated state of a process/product.
• Compiles quality impact assessments and quality approval of change control phases.

• Customer Complaints

• Awareness of complaint and quality defect investigations.
• Utilize both Global and local systems for management, investigation and reporting of customer complaints.
• Ensure all complaints are closed within specified timeframes.

• Inspection/Audit

• Ensure inspection readiness in work completed.
• Carryout cGMP compliance area walk-throughs of manufacturing as required ensuring 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

• Manage and maintain the Documentation System.
• Review and approval of Quality documentation.

• Quality System Management and Review

• Responsible for the 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

• Other

• Overview of regulatory/guidance and legislative updates relevant to Baxter
• Compilation of reports in a timely manner as requested
• Providing back up on control and issue of Quality Documentation
• Implementation, execution and administration of non-conformances
• Complete additional Quality related tasks and assignments as required by the department manager
• Compliance to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) or Good Distribution Practices (GDP), as applicable
• Review of process change controls
• Training of Quality and Manufacturing personnel
• Provide support in other Quality roles as needed.
• Compliance to Environmental Health & Safety (EHS) requirements

We are presently seeking people who have:

• QP Qualification - A MUST
• Pharmacy Degree (or equivalent) in science-related discipline essential
• Previous 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 Supervisory skills. Good interpersonal and people / team management 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 ability to manage a wide range of specific tasks
• Good organisational, coordination and communication skills

“What are some of our benefits of working at Baxter?

• Pension
• Annual Bonus
• Health Insurance
• Life Assurance
• Baxter is committed to growing and developing an inclusive and diverse workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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