Quality Assurance Specialist

About the role

Catalyx is looking for a Quality Assurance Specialist to join its on‑site team in Cork. The role works on a rotating weekly shift pattern and supports customer operations in a highly regulated environment.

Key responsibilities

• Provide quality oversight across production stages, including material inspection, in‑process control and product readiness.
• Assemble and review documentation to support product disposition and meet release timelines.
• Support packaging operations through visual inspections and process adherence.
• Collaborate with Manufacturing, Quality Control, Supply Chain, Engineering and other functions to resolve daily queries.
• Maintain and improve quality systems via change control, deviation management and CAPA oversight.
• Conduct documentation reviews (batch records, SOPs, work instructions) ensuring regulatory compliance.
• Prepare periodic quality reports, metrics and trend analyses.
• Participate in internal audits and readiness assessments.
• Provide informal coaching on GMP processes to operational teams.
• Support project‑based initiatives aimed at process enhancement and compliance.
• Review and approve manufacturing inputs and documents against release criteria.

Required profile

• Bachelor's degree in a scientific or technical discipline.
• 2‑4 years of experience in a Quality or GMP‑related role within the pharmaceutical, biotech or other regulated sector.
• Familiarity with batch documentation and quality release processes.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• Batch record review and documentation control.
• Change control, deviation management and CAPA processes.
• Internal audit execution.
• Packaging inspection and visual quality checks.
• Collaboration with cross‑functional teams in a regulated environment.