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Quality Assurance Specialist

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20683

An exciting new opportunity for a Quality Assurance Specialist to join a leading medical company based in Carlow. The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities

 Overview of Main Responsibilities

  • Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
  • Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing. 
  • QA oversight on the receipt and release of Drug Substance to site.
  • Role Functions
  • Provide quality oversight and direction for the introduction of new products, drug substance and materials onto site covering the end to end strategy.
  • Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
  • Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.


  • 3-5 years’ experience in a quality role, ideally in pharmaceutical manufacturing environments.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Knowledge of cGMP and GDP preferred
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.
  • Proven decision making capability with accountability and responsibility

For a confidential discussion and more information on the role, please contact Kevin Griffin

Kevin Griffin

(021) 2427108