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Quality Systems Specialist

https://www.baxter.com/ Logo

Baxter

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Location:
Ireland , Dublin

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Category:
Quality Control

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Contract Type:
Employment contract

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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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