QA Specialist

Job description

QA Specialist

To implement and maintain Quality Assurance actions in compliance with the current GMP regulations.


Key Responsibilities:

  • Implementation, maintenance and development of QA systems
  • Reviewing the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc
  • Writing and reviewing QA department procedures and reports
  • Internal Auditing of FLI Departments and external auditing of Service Suppliers
  • Participation in change control activities on site
  • Assist in the preparation and reviewing of QA department reports and metrics
  • Environmental Monitoring –  review of data, monthly report , NCRs, Annual Report
  • Assist in New Product Introduction Activities when required
  • Contribute to the quality assessment of clinical, pre-commercial product
  • Contribute to the quality assessment of commercial finished product
Education & Experience:
  • Relevant 3rd level degree in science or quality
  • Minimum 3 years pharmaceutical experience in a regulated environment would be preferable.
  • QP certification advantageous
  •  Experience in pharmaceutical environment a significant  advantage.
  • Knowledge of GMP. 
  • Good organisation skills and time management.
  • Analytical approach to problem solving.

If you meet the desired criteria above please send your CV to or phone 01 4744676 for a confidential discussion.

This is not a graduate role.