Quality Systems Professional

7 days ago

Cork, Cork, Ireland beBeeQualityAssurance Full time €50,000 - €80,000
Quality Assurance Specialist Role Overview

Catalyx is a trusted partner in delivering lifecycle services to regulated and high-risk end markets. We empower life science and other highly regulated organisations to enhance efficiency and drive success.

This role involves providing quality oversight across various production stages, including material inspection, in-process control, and product readiness activities. You will work closely with operational and quality colleagues to meet release timelines.

The ideal candidate will have a strong background in quality or GMP-related roles within the pharmaceutical, biotech or related regulated sector. Familiarity with batch documentation, quality systems, and regulatory expectations is essential.

Responsibilities include:

  • Providing quality oversight and conducting visual inspections.
  • Assembling and reviewing documentation to support product disposition.
  • Supporting packaging operations and process adherence during routine activities.
  • Collaborating with cross-functional teams to resolve day-to-day queries and issues efficiently.
  • Contributing to the maintenance and improvement of quality systems through change control, deviation management, and CAPA oversight.
  • Conducting documentation reviews and ensuring alignment with regulatory and internal standards.
  • Preparing periodic quality reports and metrics to support trend identification and ongoing improvement.
  • Engaging in internal audits and readiness assessments to ensure site and process compliance.
  • Providing knowledge-sharing and informal coaching on quality processes to enable operational teams to work effectively within GMP frameworks.
  • Supporting project-based work and initiatives aimed at process enhancement and improved compliance practices.
  • Reviewing and approving manufacturing inputs and documents to ensure compliance with release criteria.

Requirements for this position include:

  • Bachelor's degree in a scientific or technical discipline.
  • Minimum 3 years' experience in a Quality or GMP-related role within the pharmaceutical, biotech or related regulated sector.
  • Familiarity with batch documentation, quality systems, and regulatory expectations.
  • Strong analytical skills and ability to identify corrective actions.
  • Experience supporting or interacting with packaging or material management processes is beneficial.
  • Strong written and verbal communication skills; confident working in a collaborative environment.
  • Competence with Microsoft Office tools, particularly Excel and Word.
  • Organised, detail-focused, and capable of managing multiple priorities.
  • Comfortable working independently within defined parameters, and adaptable to shifting project needs.

Catalyx is an Equal Opportunity Employer committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.

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