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.
Education and Experience:
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.
#J-18808-Ljbffr