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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 Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Authorization awarded by the Health Products Regulatory Authority (HPRA). The Quality Systems Specialist is responsible for ensuring that systems and products manufactured in the Dublin Compounding Facility align with the Manufacturing Authorisation Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.
Essential duties and Responsibilities
- Quality Systems
- Ensure the compilation of Quality Management Review process.
- Review and approval of process change controls, SOPs, NCRs and CAPAs.
- Implementation, execution and administration of Change Control System and NCR System in accordance with the relevant SOP’s at Baxter Dublin Facility and to coordinate the follow up and closure of all open items in relation to both.
- Administration of Recall process with the Quality management team.
- Administration/co-ordination of risk assessments.
- Support facility projects including process development and quality improvement initiatives
- Manage and maintain the Documentation System. Manage of site archive, storage, retrieval and destruction processes.
- Review and approval of Quality documentation.
- Supporting all departmental administration systems as required
- To assist with the collation of information and assist in the preparation of reports in relation to Annual Product reviews for all products manufactured on site.
- To ensure that the systems with a GMP impact are maintained as per written procedures, that good GMP standards are always maintained. To ensure company procedures regarding controlled drugs are followed and assist in the audit of logbooks as required.
- Training
- Training of Quality and Manufacturing personnel
- Train and provide feedback to document/process owners on errors for continuous improvement, as well as CGMP compliance.
- Self-Inspection/Regulatory audits
- Ensure inspection readiness in work completed.
- Assist in the internal and external audit program. Participation in regulatory and corporate / internal audits. Conduct audits as per internal audit schedule.
- Compile and track internal/corporate audit and regulatory inspection responses.
- Metrics
- Support trending and compilation of investigation/system reports in a timely manner – Deviation trend reports, Annual inspection report, Quality Management Review reports.
- Preparation of Key Performance Indicators
- Customer Complaints
- To administer and develop the complaints system, in accordance with the relevant SOP’s and to coordinate the follow up and closure of all open items. Ensure all complaints are closed within specified timeframes.
- Supplier
- To monitor the Approved Supplier listing (TW9) which is inclusive of ensuring that all quality agreements are in place.
- Manage supplier complaints and investigation processes.
- Administration of supplier notification/change processes.
- Changes/New projects/Periodic reviews
- Support the introduction of new products
- 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 follows applicable procedures and maintain a validated state.
- Other
- Support the implementation of the Operational Excellence Programme on the site by identifying and implementing improvements.
- Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
- Compliance to Environmental Health & Safety (EHS) requirements
- Support the site-wide Quality Department
- Any other duties as assigned by the Quality Manager.
Education and/or experience
- Degree or equivalent experience in Science or related field
- Post qualification experience of at least 1 years in a GMP environment, ideally in a quality role!
- Experience in dealing with Regulatory Compliance desired.
- Good problem solving and investigation skills would be beneficial
Skills
- An ability to work in a dynamic, fast-paced and goal driven environment. Be dedicated.
- Meticulous in attention to professional standards
- Good professional standards 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
- Excellent organisational, coordination and communication skills
- Ability to manage a wide range of specific tasks, with very good influencing and interpersonal skills
“What are some of our employee benefits working at Baxter?
- Pension
- Health Insurance
- Life Assurance
- Baxter is committed to growing and developing their workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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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.
Recruitment Fraud Notice
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