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Here, you will find more than just a job—you will find purpose and pride.
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 comply with the Manufacturing Authorization, 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 (KPIs)
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 compliant with 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 in Science or related discipline
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 self-driven.
Meticulous in attention to professional standards
Respond well to time constraints
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
Very good influencing and interpersonal skills
What are some of our benefits of working at Baxter?
Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Pension
Health Insurance
Life Assurance
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Equal Employment Opportunity
Baxter is an equal opportunity employer.
Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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***** Furze Road Sandyford Ind Est|Dublin|Co.
Dublin|Ireland
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