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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 R&D, 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 enhance efficiency and drive success. We are continuously developing our on-site teams to support the advancement of customer operations. To learn more, visit www.catalyx.ai.
Responsibilities and Tasks:
* Serve as a labeling expert across Regulatory, Legal, Graphic Designers, Package Engineers, Quality Assurance, and Materials Management functions.
* Contribute to the completion of operational activities and projects where precedents may not be set, requiring innovative problem-solving.
* Manage complex processes across functions, ensuring timely product labelling implementation.
* Coordinate the implementation of new labelling with Materials Management across multiple sites.
* Recommend improvements and develop systems/SOPs based on novel approaches to existing processes to enhance labelling operations.
Skills and Experience Required:
* 6+ years of relevant experience with a BS or BA degree
* 4+ years of relevant experience with an MS degree
* 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
* Strong knowledge of FDA cGMP standards and regulatory guidance documents
Why Join Catalyx?
At Catalyx, we value our people as our greatest asset. Our Total Rewards package includes personal benefits and professional growth opportunities.
Catalyx is an Equal Opportunity Employer committed to diversity and inclusion. We do not discriminate based on race, religion, gender, age, disability, or other protected characteristics. We encourage applications from all qualified candidates and support international employees with assistance for Critical Skills Visa applications.
Additional Details:
* Seniority level: Mid-Senior level
* Employment type: Contract
* Job functions: Project Management and Product Management
* Industries: Pharmaceutical Manufacturing, Biotechnology Research, Medical Practices
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