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Documentation Specialist | Sligo

  • Sector: Office Support
  • Contact Email: chloe.somers@collinsmcnicholas.ie
  • Job Ref: 20168

Our client, a leading biopharmaceutical company, is keen to hire a Documentation Specialist to join their team in Sligo on an initial 12-month contract.

This role will involve working as part of the biologics operations team.

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

  • Managing 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
  • Coordinate the execution of CAPA plan related to the sterility assurance of the department
  • Receive, review, and format documents in preparation for the Change Request process
  • Manage the site record retention process
  • Assist with external audits and inspections through the coordination, preparation and compilation of document packages for audits 

(Full spec available upon request)

Requirements

  • A third-level qualification in a science, quality or relevant discipline
  • Experience working an aseptic sterile fill finish manufacturing environment or other Regulated industry
  • Proficient in Microsoft Office applications

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

chloe.somers@collinsmcnicholas.ie

071-9140254