Job Title: Label Ops Project Coordinator
Location: Cork, Ireland (hybrid work model)
Catalyx is a science-driven company that specializes in the operational processes. With a global presence in North America and Europe, we carefully automate and service R&D, production, packaging, and delivery processes globally using sophisticated products, technologies, and lifecycle services.
We are a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. Our commitment to innovation and excellence drives us to partner with life science and other highly regulated organizations to enhance efficiency and drive success.
To support our customers' operations, we continuously develop our on-site teams.
Key Responsibilities:
* Schedule artwork updates as required, ensuring timely implementation and generation of associated documentation/PR/system updates.
* Communicate updates, risks, and escalations in real-time to team leads and management.
* Support additional project coordinator activities, including ARCO release, ATO, LO representation at site meetings/boards for launches & artwork updates.
* Coordinate and create change controls, deviations, CAPAs, change assessments, ASPVM updates, SOP & process updates as required.
* Implement process improvements within Label operations & purchasing.
* Train other team members and participate in collaborative projects where required.
* Represent LO in internal/external audits in support of coordination activities.
Coordination Activities:
* Create and coordinate approval of documents to support Labelling activities, liaising cross-functionally as required.
* Liaise with print vendors and multiple functions to ensure timely implementation of artwork.
* Creation and update of Commercial Formula for Label Ops, where required.
* Setup of Artwork Change Order and associated items for Label Ops, where required.
* Provide backup to the Data Steward role where required.
Requirements:
* 3+ years of relevant experience and associated qualifications.
* Prior experience in a related industry, including 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.
* Familiarity with FDA cGMP standards and regulatory guidance documents.
* Able to work independently with attention to detail and accuracy.
Why Join Catalyx?
Catalyx values its people and provides a Total Rewards package, including great personal benefits and professional growth opportunities. We are an Equal Opportunity Employer committed to creating a diverse and inclusive workplace. We welcome applications from all qualified candidates and strive to create a welcoming environment for everyone.