Chief Compliance Officer

2 weeks ago

Cork, Cork, Ireland beBeeValidation Full time €80,000 - €120,000

Job Summary

Catalyx is seeking an experienced IT Validation Specialist to join our team working within the pharmaceutical sector.

This role is critical in ensuring that all IT systems and software comply with regulatory standards, operational requirements, and industry best practices.

  • Manage the qualification of IT systems, including hardware, software, and infrastructure within a GMP lab setting.
  • Validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
  • Collaborate with software vendors to ensure system validation documentation is complete and accurate.
  • Manage the lifecycle of validated software, including upgrades and decommissioning.
  • Perform periodic reviews of validated systems to ensure continued compliance.
  • Develop and maintain traceability matrices to ensure alignment with user requirements.
  • Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Author, review and approve validation documentation, including validation plans, reports, and risk assessments.
  • Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11, and EMA guidelines.
  • Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.

About Catalyx

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services.

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