C

Quality Assurance Specialist

Ireland
Visa Sponsorship Relocation
This Job is No Longer Active This position is no longer accepting applications

Join Catalyx as a Quality Assurance Specialist to provide quality oversight across various production stages, assemble and review documentation, and collaborate with cross-functional teams to resolve day-to-day queries and issues efficiently. This role requires a Bachelor's degree in a scientific or technical discipline and 3-5 years' experience in a Quality or GMP-related role within the pharmaceutical, biotech or related regulated sector. Key requirements include familiarity with batch documentation, quality systems, and regulatory expectations, as well as strong written and verbal communication skills.

Key Highlights
Provide quality oversight across various production stages
Assemble and review documentation to support product disposition
Collaborate with cross-functional teams to resolve day-to-day queries and issues efficiently
Key Responsibilities
Provide quality oversight across various production stages, including material inspection, in-process control, and product readiness activities.
Assemble and review documentation to support product disposition, working closely with operational and quality colleagues to meet release timelines.
Support packaging operations by conducting visual inspections and ensuring process adherence during routine activities.
Collaborate with cross-functional teams (Manufacturing, Quality Control, Supply Chain, Engineering, etc.) to resolve day-to-day queries and issues efficiently.
Contribute to the maintenance and improvement of quality systems through change control, deviation management, and CAPA oversight.
Conduct documentation reviews such as batch records, SOPs, and WI updates, ensuring alignment with regulatory and internal standards.
Participate in the preparation of periodic quality reports and metrics, supporting trend identification and ongoing improvement.
Engage in internal audits and readiness assessments to ensure site and process compliance.
Provide knowledge-sharing and informal coaching on quality processes to enable operational teams to work effectively within GMP frameworks.
Support project-based work and initiatives aimed at process enhancement and improved compliance practices.
Review and approve manufacturing inputs and documents to ensure compliance with release criteria.
Technical Skills Required
Quality systems Regulatory expectations Batch documentation
Benefits & Perks
Total Rewards package
Critical Skills Visa applications for eligible candidates
Paid relocation

Job Description

Catalyx is seeking a Quality Assurance Specialist to join our team and work on our customer site in Cork.

This role operates on a rotating weekly alternating shift pattern.

Who We Are:

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