Label Ops Project Coordinator

Catalyx are seeking a Label Ops Project Coordinator to join our team and work on our customer site in Cork on a hybrid work model 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 processesgloballywith 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 Responsibilities and Tasks: Support the coordination of artwork updates as required ensuring no missed implementation dates (including the generation of associated documentation /PR/system updates as required). Provide real time communication of updates/risks/escalation to team leads /management Support Additional Project Co Ordinator activities including but not limited to ARCO release, ATO, LO representation at site meetings/boards in support of launches & artwork updates. Support the coordination & creation of Change controls, deviations, CAPAs, Change assessments , ASPVM updates, SOP & process updates as required Support the implementation of process improvements within Label operations & purchasing. Assists in the training of other team members Participates in collaborative projects where required, interactive with internal and external resources. As required represent LO in internal / external audits in support of coordination activities. Manages coordination activity for Labelling Operations, specifically as follows: Creates and coordinates approval of documents to support Labelling activities, liaising cross functionally as required Liaises with the print vendors, and across multiple functions to ensure the timely implementation of artwork Creation and update of Commercial Formula for Label Ops, where required. Set up of Artwork Change Order and associated Items for Label Ops, where required. Provides back up to the Data Steward role where required; Creation and update of items for all required item types in the applicable system, for Processing all requests for new items, or updates to existing items for Creation and update of Commercial Formula, where required. Creation and update of GxP manufacturers Processing all requests for new manufacturers, or updates to existing manufacturers Ensuring all master data adheres to the Data Standard Requirements Ensuring all the correct linkages are made between items, manufacturers, commercial formula etc. so that the system generated reports are accurate and correct. Recommends improvements and develops systems / SOPs to enhance the coordinator process SOP/document management: Adheres to SOPs to maintain standards and quality Develops SOPs for relatively complex processes Participate in the SOP/document management for the wider Labelling Operations team Skills and Experience Required: 3+ years of relevant experience and associated qualifications. Prior experience in a related industry including experience with product launches & packaging. Excellent verbal, written, and interpersonal communication skills with internal and external customers. Strong computer skills and excellent organizational skills. Proficient in PC environment; MS Office Possesses a strong knowledge of FDA cGMP standards and regulatory guidance documents. Able to work independently. Demonstrates attention to detail and accuracy. Why Join Catalyx? At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone. At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates. Skills: Project Management Quality Control