Quality Systems Specialist, Baxter

Quality Systems Specialist

Baxter

Location:

Ireland, Dublin

Category:

Quality Control

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufacturing Authorization awarded by the Health Products Regulatory Authority. The Quality Systems Specialist ensures that systems and products manufactured in the facility align with GMP, Irish and European Legislation, and Baxter Healthcare Ltd Standards.

Job Responsibility:

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
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 site archive, storage, retrieval and destruction processes
review and approval of Quality documentation
assist in the collation of information and preparation of reports for Annual Product reviews
ensure systems with GMP impact are maintained
training of Quality and Manufacturing personnel
train and provide feedback to document/process owners
ensure inspection readiness in work completed
assist in internal and external audits
compile and track audit and inspection responses
administer and develop the complaints system
manage supplier complaints and investigation processes
monitor the Approved Supplier listing
support the introduction of new products
improve efficiencies and promote continuous improvement
ensure compliance to GMP and EHS requirements
support site-wide Quality Department

Requirements:

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
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

Nice to have:

Good problem solving and investigation skills
experience in dealing with Regulatory Compliance

What we offer:

Pension
Health Insurance
Life Assurance
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:

March 21, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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