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Compliance Specialist | Sligo

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

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

  • Ensure that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.
  • Providing quality and compliance oversight and assistance to the Operations function of the company
  • Provide quality oversight during the aseptic processing of products
  • Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance
  • Review/Audit of completed Batch Records
  • Completion of Incoming Raw Material checks, including product status maintenance
  • Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation
  • Administration of Quality Logs, e.g. QA Hold, Sample Request, VCR

(Full spec available upoun request)

Requirements

  • A third level qualification in a science, quality or relevant discipline
  • Previous experience working in a quality or similar position
  • Experience working in a regulated enviroment
  • Previous Biologics sector experience would be an advantage

To find out more information on this Compliance Specialist role, please contact Chloe Somers

chloe.somers@collinsmcnicholas.ie

071-9140254