Compliance Documentation Specialist

  • Contract
  • Cork

Website Ref: TPM03860

A Compliance Documentation Specialist is required for a biotech company in West Cork. The successful candidate will provide compliant, accurate and timely documentation support. They will also ensure the timely generation and approval of all key documents supporting the program schedule.


  • The Compliance Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within the Warehouse team.
  • Contribute to the High-Performance culture within the group by providing a flexible, accurate service to enable the achievement of key priorities.
  • Be an active member of the cross functional Supply Chain team, providing support, guidance and expertise to ensure the success of the department.
  • Participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant.
  • Supporting the Compliance culture of the Supply Chain team.
  • Supporting Audits for Supply Chain in Quality, EHS, and Cost etc as needed.
  • Updating/deletion of documents through the MIDAS/QUAL Doc system.
  • Preparation of change control documentation on TrackWise System.
  • Tracking of GCM tasks on TrackWise System.
  • Processing of documentation through the Change Control System.
  • Supporting Continuous Improvement updates for the team.
  • Supporting documents linked to the Model Area project.

Qualifications & Experience:

  • Minimum Leaving Certificate.
  • Qualification in a science/engineering/technical subject is desirable.
  • Evidence of Continuous Personal Development is an advantage.
  • Six Sigma Yellow Belt is an advantage.
  • Experience with SAP, MIDAS, TrackWise, Change Control is desirable.
  • High level technical writing skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.

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