Catalyx is seeking a QA Specialist to join our team and work on our customer site in Cork. The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers.

WHO WE ARE:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services RD, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company’s experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

SKILLS AND EXPERIENCE:

• A relevant third-level qualification in a QA discipline.
• A minimum of 2-3 years of relevant industrial experience in a QA role, preferably in the pharmaceutical sector.
• Experience with Batch Record Review in Pharma/Med Devices is essential.
• Demonstrable understanding of Document Control principles, Quality Systems, and GMP requirements.
• Comprehensive knowledge of document control processes and the relationship between document change processes and products.
• Familiarity with the current pharmaceutical industry and relevant regulations, including 21 CFR, GxP, and ICH guidelines.
• Proficiency with Electronic Document Management Systems (EDMS).
• Stay informed about compliance requirements in your work area.
• Exhibit strong problem-solving skills with attention to detail.
• Proficiency in Microsoft Office applications and experience with Oracle.
• Excellent written and verbal communication skills, coupled with strong interpersonal skills.
• A proactive attitude toward customer service and performance.

THE ROLE:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

RESPONSIBILITIES:

• Deliver Quality Assurance support to the Packaging Department.
• Evaluate and approve GxP documentation.
• Conduct Batch Record Review and Batch Disposition processes.
• Update Quality Assurance Standard Operating Procedures (SOPs) as necessary.
• Scan and archive documents as needed.
• Inspect finished products.
• Perform investigations into deviations and conduct Root Cause Analysis.
• Generate reports for customer complaints.
• Conduct line clearance for packaging areas.
• Suggest process enhancements and recommend changes.
• Assist with internal and regulatory audits/inspections as required.
• Support the training and mentoring of new employees.
• Provide additional support and assistance on tasks and projects as directed by management.
• Collaborate with cross-functional teams.
• Achieve agreed-upon KPIs and metrics.
• Perform other duties as necessary.