Quality Control Specialist – NPI & Network Testing
Our client, a leading pharmaceutical company based in Carlow, is seeking applications for a Specialist, Quality Control NPI and Network Testing.
This person will be part of the integrated QC NPI and Network Testing team, contributing to a strong culture of quality and operational excellence.
This role involves overseeing QC readiness activities related to new product introductions, as well as coordinating testing activities both on-site and across the broader network in collaboration with global stability teams.
Responsibilities
Lead QC NPI and network testing activities, including demand planning across internal and external networks, cross-site coordination, and implementation of QC requirements to support the site's product testing portfolio in line with regulatory expectations
Coordinate testing performed across internal network laboratories and external contract testing facilities, including investigation of out-of-specification (OOS) and out-of-trend (OOT) results, and communication with project teams (biologics, vaccines, and/or devices)
Collaborate with internal and external stakeholders in a cross-functional environment to ensure compliance and operational excellence in all testing activities
Ensure laboratory sample management and reporting procedures, along with associated systems (e.g. GLIMS, SAP), are maintained to support NPI and network testing requirements
Execute deviations, investigations, and change management records; manage GMP documentation including GLIMS updates, SOPs, and data integrity practices
Support the preparation and approval of Annual Product Reviews
Contribute to documentation required for new product registrations and batch reallocations
Assess the impact of pharmacopeia and quality standard updates on network testing activities
Lead and participate in continuous improvement initiatives and QC Hoshin projects
Requirements
3–5 years of experience in the pharmaceutical, biopharmaceutical, or similar regulated environment, including experience in a QC function
Ability to make decisions within established guidelines and effectively manage priorities to meet deadlines
Degree in Science, Engineering, or a related discipline
Strong knowledge of cGMP within laboratory quality systems
Familiarity with laboratory testing regulatory requirements
Proficiency in Microsoft Office and relevant computer applications
Experience in report writing, standards, and policy development
Ability to work independently and drive improvement initiatives with moderate guidance
Strong communication and interpersonal skills, with the ability to collaborate across teams
Experience with Lean tools such as value stream mapping, standard work, tier processes, problem solving, Leader Standard Work, 5S, A3 thinking, Hoshin Kanri, change management, waste identification, poka-yoke, and Kanban
Proven ability to deliver results, make decisions, and solve problems effectively
Required Skills
Communication, Continuous Improvement, GMP Compliance, Leadership, Quality Management, Quality Management Systems (QMS), Regulatory Knowledge, Stability Programs, SOP Development, Strategic Collaboration, Teamwork, Technical Writing, Troubleshooting.
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