Quality Assurance Specialist – Sterile Manufacturing

About the role

We are seeking a Quality Assurance Specialist to join a leading multinational pharmaceutical manufacturer in Westport. The role operates on a 4‑shift, 12‑hour cycle supporting sterile manufacturing operations and ensuring compliance with cGMP standards.

Key responsibilities

• Provide QA support to IPT production teams, maintaining cGMP standards.
• Perform timely reviews of batch documentation (EBR), line clearances and assist in resolving risk‑based concerns.
• Monitor and report quality metrics to ensure audit readiness and continuous compliance.
• Support spot‑check and walk‑through processes on production lines.
• Participate in customer complaint investigations when required.
• Liaise with cross‑functional departments to drive improvements in GMP and quality standards.

Required profile

• Bachelor’s degree or higher in a scientific discipline (preferred).
• 1‑2 years experience in a quality role within pharmaceutical manufacturing, preferably aseptic.
• Understanding of Irish, European and international regulatory requirements.
• Ability to work effectively in a shift‑based, fast‑paced environment.

Required skills

• Sterile manufacturing processes
• SAP
• MES
• Trackwise
• cGMP and GDP knowledge
• Electronic Batch Records (EBR) review
• Regulatory compliance (US, EU)