Associate Quality Assurance Specialist
Hybrid
RK26094
Contract 11 months
Tipperary



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. 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:

• Act as a functional QA expert within cross-functional teams to support project introduction and Right First Time performance.
• 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.

• 2–3 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.
• 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.