Catalyx are seeking a Senior Label Ops Project Coordinator to join our team and work on our customer site in Cork

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.
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. To learn more about the company’s experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

SKILLS AND EXPERIENCE REQUIRED:

• 6+ years of relevant experience and a BS or BA
• 4+ years of relevant experience and a MS
• Prior experience in the pharmaceutical industry is preferred
• Proficient knowledge of Good Manufacturing Practices (GMPs)
• Strong verbal, technical writing and interpersonal skills.
• Proficient in Microsoft Office applications
• Possesses a strong knowledge of FDA cGMP standards and regulatory guidance documents.

• Seen as labeling expert across Regulatory, Legal, Graphic Designers, Package Engineers, Quality Assurance, and Materials Management functions.
• Contributes to the completion of all operational activities projects where prior precedents may not be set and outcomes require operating with prior experience.
• Manages the most complex processes across functions and interacts effectively with the other team members to ensure product labelling implementation timing is met.
• Responsible for the coordination of implementing new labelling with Materials Management and at multiple sites.
• Based on novel approaches to existing processes, recommends improvements and develops systems/ SOPs to enhance labelling operations.