Quality Systems Specialist

BAXTER HEALTHCARE PTY AUS

Dublin, Ireland
Quality management review
Change control system administration
Sops, ncrs, capas review
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

Job Summary

  • 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.
  • Key responsibilities include managing change controls, SOPs, NCRs, CAPAs, administering recall and risk assessment processes, and maintaining the documentation system.
  • Baxter offers a competitive total compensation package, professional development opportunities, and places high importance on work-life balance, including benefits like Pension, Health Insurance, and Life Assurance.

Matching Summary

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.

Skills & Requirements

Must-have

  • Quality Management Review
  • Change Control System administration
  • SOPs, NCRs, CAPAs review
  • GMP compliance
  • Documentation System management
  • Audit program participation

Nice-to-have

  • Continuous improvement initiatives
  • Operational Excellence Programme
  • Work life balance
  • Self-driven and motivated

Key Requirements

  • Degree in Science or related discipline
  • 1+ years GMP environment experience
  • Regulatory Compliance experience desired
  • Good problem solving skills

Work Rights

Not specified

Tailored Resume

Cover Letter