Catalyx is seeking a Project Coordinator to join our team and work in the Label Ops department 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 organizations 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 and Tasks:
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.Coordination and creation of Change Control in support of the Labelling Department in Quality Systems.Provides backup to the Data Steward role where required.Creation and update of items for all required item types in the applicable system.Processing all requests for new items or updates to existing items.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.Assists in the training of other team members.Participates in collaborative projects where required, interacting with internal and external resources.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. Project management experience is an advantage. 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.
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