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Quality Compliance Specialist (Internal Audits)

Dublin, Ireland

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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Quality Compliance Specialist (Internal Audits)

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Job ID R0022352 Date posted 04/06/2021 Location Dublin, Ireland

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Job Description

The Quality Compliance specialist is responsible for leading the internal audit program on site, including supporting regulatory and customer inspections. The Quality Compliance Specialist will have specific and varying duties as assigned by the Quality Systems & Compliance Manager.Some key tasks and responsibilities are outlined below;

  • Manage the internal audit programme including preparation of annual schedule
  • Execution of internal audits as per schedule
  • Oversight of GMP Inspections and Quality on the Shop Floor program
  • Prepare all associated documentation including audit plans and audit reports
  • Reporting on metrics and KPIs to senior leadership team
  • Communication of audit findings to individual departments and senior leadership team
  • Follow-up on CAPA actions identified ensuring closure in timely manner
  • Establishment of site internal audit team
  • Training of internal audit team as required
  • Lead regulatory Health Authority and Customer Inspections as required, including acting as SME for specific topics as necessary
  • Act as compliance subject matter expert regarding GxP Interpretations for all levels of Management
  • Perform external audits of suppliers as necessary
  • Participate in cross-functional project teams as the quality compliance representative
  • Participate in Continuous Improvement programmes
  • Participate in other projects as directed by the Quality Systems & Compliance Manager.
  • Flexibility is important and responsibilities may change, or other duties may arise for this position

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0022352
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