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Quality auditor

Tipperary
Next Generation Recruitment
Quality auditor
Posted: 11 June
Offer description

OverviewJoin the Quality Frontline of Digital Compliance: QA Associate Specialist (eLogs & Data Integrity)Imagine being part of a critical site project strengthening data integrity compliance through the introduction of electronic logbooks, where your QA expertise ensures systems are compliant, robust, and inspection ready. This is your chance to play a key role in a GMP-regulated environment where quality systems and digital transformation meet.ResponsibilitiesAct as a QA representative within a cross-functional project team supporting implementation of electronic logbooks (eLogs) across Operations, QC, and Warehouse/Logistics.Provide QA oversight into the design and implementation of eLogs, ensuring alignment with ALCOA+ Data Integrity principles and global QMS requirements.Apply quality systems knowledge to ensure robust system design, including risk identification and control implementation.Partner with cross-functional stakeholders to ensure solutions are practical, compliant, and fit for purpose.Support process mapping and risk assessments to ensure appropriate data capture and system design.Drive continuous improvement initiatives by identifying recurring issues and implementing sustainable improvements.Support change control, CAPA, and deviation activities linked to project implementation.Escalate risks and support decision-making within the project team.Contribute to inspection readiness and ensure systems meet regulatory expectations.Qualifications2-3 years' experience in a GMP-regulated environment (QA, QC, Operations, Supply Chain, or Quality Systems).Experience supporting system implementation or project introduction in a regulated setting.Strong understanding of Data Integrity and ALCOA+ principles.Working knowledge of Quality Systems including deviations, CAPA, and change control.Strong cross-functional collaboration and stakeholder management skills.Exposure to electronic systems such as SAP, Veeva, Kneat, or similar.Experience supporting audits or inspection readiness activities.Lean or continuous improvement exposure advantageous.
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