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Documentation Specialist

  • Sector: Office Support
  • Contact Email:
  • Job Ref: 21105

Our client, a leading biopharmaceutical company, is hiring a Documentation Specialist to join their team in Sligo on a 6-month contract.

As a Documentation Specialist, you will be responsible for the following:

  • Manage the company’s document control system and change control system, ensuring compliance to site, cGMP and Regulatory requirements
  • Ensure the accuracy, quality and integrity of documents
  • Ensure that controlled copies of latest approved documents and drawings are available at defined locations
  • Preparation of reports and metrics showing the effectiveness of the documentation system, batch release process and product release
  • Receive, review, and format documents in preparation for the Change Request process
  • Manage the site record retention process
  • Prepare batch documentation
  • Review executed batch documentation to ensure compliance to site, cGMP and Regulatory requirements
  • Release approved product per agreed schedule
  • Assist with external audits and inspections through the coordination, preparation and compilation of document packages for audits 


  • Minimum of 2 years document control and records management experience in a Regulated industry
  • Expertise with Microsoft Word with a solid understanding of the review and formatting tools 
  • Expertise with Outlook, Visio, Excel, PowerPoint  

For more information on this Documentation Specialist role, please contact Chloe Somers

071 9140254