Quality Control NPI Specialist

Quality Control NPI Specialist
Hybrid
RK25857
Contract 12 months
Carlow



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Key Responsibilities:

• Lead QC NPI and network testing activities, including NPI demand planning across internal and external networks, cross‑site coordination, and implementation of QC NPI requirements to support product testing portfolio in accordance with regulatory expectations
• Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence for testing to be performed at or behalf of the site
• Coordination of testing activities performed across both internal Network and contract testing facilities , investigating out of specification/ out of trend results, and communication with integrated project teams for biologics, vaccines, and/or devices
• Ensure the Lab sample management and reporting procedures, together with associated systems ( e.g GLIMS/ SAP) are maintained to Support NPI and Network testing requirements.
• Execute deviations and investigations, Change Management records, manage GMP documentation including GLIMS updates, Standard Operating Procedures (SOP), and GMP data management.
• Support authoring and approval of Annual Product Review
• Support document requirements for new product registrations and batch reallocations
• Assessment of network testing impact as a result of Pharmacopeia and Quality standard updates
• Lead and participate in improvement projects and QC Hoshins within the area.

• 3-5 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a QC function.
• Degree in Science, Engineering or similar
• Experience in elements of the lean toolkit including value stream and process mapping, standard work, tier process, problem solving, Leader Standard Work, 5S work place organization, Strategic A3 thinking, Hoshin Kanri, managing change, 8 wastes identification, poka yoke and Kanban.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Knowledge of cGMP in Laboratory Quality Systems.