Associate Quality Specialist-Hybrid

Tipperary, Ireland Posted on 05/22/2026

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• Country Ireland

Job Description

Associate Quality Specialist supports project for strengthening data integrity compliance for electronic logs and day-to-day QA activities in the facility. The Quality Specialist participates as a core member of the Quality Systems CoE Team.

Act as a QA representative within a cross-functional project team to support the design, introduction, and continuous improvement of electronic logbooks (eLogs) across Operations, Quality Control, and Warehouse/Logistics. Ensure alignment with ALCOA+ Data Integrity principles and global QMS requirements.

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.

Experience & Skills

• 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.
• Demonstrated understanding of Quality Systems, including deviations, CAPA, and change control processes.
• Proven ability to work effectively in cross functional teams and influence stakeholders.
• Strong communication, problem solving, and decision making skills.
• Experience with electronic logbooks or digital systems in manufacturing, laboratory, or warehousing environments.
• Knowledge of quality IT systems (e.g., SAP, Veeva, Kneator, or similar).
• Experience supporting or participating in internal audits or inspection readiness activities.
• Exposure to lean / continuous improvement methodologies.