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QA Specialist

Full-Time Australia, Australia
Health & Biotech
Health & Biotech
28 March 2024
  • Maintain the Documentation Management System (eDMS) as the System Administrator for the Affiliate and support the JAPAC region as required.
  • Act as System Administrator for the Quality eLearning Management System (eLMS)
  • Ensure training curriculums are established and maintained within eLMS and regularly reviewed with cross-functional leaders.
  • Integration of local quality regulations for drugs, biologics, devices, and/or combination products and cosmetics.
  • Design effective quality systems, procedures and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality systems.
  • Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
  • Plan, prepare, review, and approve quality documentation such as change controls, product reviews and other local requirements.
  • Support self-inspections, and internal, external and MoH audits as directed by the manager.
  • Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.
  • Monitor metrics and KPIs to ensure compliance.
  • Support the Management Review process for the affiliate
  • Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
  • Excellent computer skills, including Microsoft Office and Visio
  • Strong written and oral communication skills
  • Good time management skills
  • Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics.
  • General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations.
  • Ability to support projects as a team member as assigned by manager.
  • Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Make decisions in collaboration with management.
  • Acts as an owner - use available resources to independently complete assigned tasks.


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