Overview
Quality Assurance Specialist Jobs in Tipperary, County Tipperary, Ireland at Tandem Project Management Ltd.
Title: Quality Assurance Specialist
Company: Tandem Project Management Ltd.
Location: Tipperary, County Tipperary, Ireland
Summary:
Our client, a biopharmaceutical company located in Tipperary, is seeking a QA Specialist. The successful candidate will support the design, introduction, and continuous improvement of electronic logbooks (eLogs) across Operations, Quality Control, and Warehouse/Logistics. The ideal candidate will also ensure alignment with ALCOA+ Data Integrity principles and global QMS requirements.
Responsibilities:
• Act as a functional QA expert within cross-functional teams to support project introduction and Right First Time performance across our clients site.
• Provide QA oversight and input into the design and implementation of eLogs, ensuring alignment with Data Integrity expectations and global QMS standards.
• Apply strong quality systems knowledge to ensure robust design, including identification of risks, root cause considerations, and appropriate controls.
• Partner with stakeholders across Operations, QC, and Warehouse/Logistics to ensure solutions are practical, compliant, and fit for purpose.
• Support process mapping and risk assessments to ensure appropriate system selection and data capture approaches.
• Drive continuous improvement initiatives, identifying recurring issues and implementing sustainable system/process improvements.
• Support or lead elements of change control, CAPA development, and deviation considerations related to the project implementation.
• Communicate effectively across stakeholders, escalating risks and supporting decision-making where required.
• Contribute to maintaining inspection readiness, ensuring solutions meet regulatory expectations and withstand audit scrutiny.
Qualifications & Experience:
• Degree in relevant discipline
• Minimum 3 years’ experience in a GMP-regulated environment (QA / QC / Operations / Supply Chain / Quality Systems or similar).
• Experience supporting project introduction or system implementation in a regulated setting.
• Strong working knowledge of Data Integrity and practical application of ALCOA+ principles.
• Demonstrated understanding of Quality Systems, including deviations, CAPA, and change control processes.
• Experience with electronic logbooks or digital systems in manufacturing, laboratory, or warehousing environments.
• Knowledge of quality IT systems (e.g., SAP, Veeva, Kneat or similar).
• Experience supporting or participating in internal audits or inspection readiness activities.
• Exposure to lean / continuous improvement methodologies.
