Job Description

Join 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.

What you'll achieve (and why it matters):
Unleash your passion and expertise to:

• Act 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.

Your edge (desired, not required):

• 2–3 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.
  
  

This isn’t just a QA role; it’s a chance to strengthen how critical data is captured, controlled, and trusted across a GMP site.

The Next Step for you:

Should this position be of interest to you please forward your CV to danielle.johnson@nextgeneration.ie from Next Generation Recruitment or apply on our website.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operations (permanent, contract and temporary) positions.

Applications are in strict confidence.

Next Generation will never share your data outside of our organisation without your prior written consent.