Associate Quality Specialist

Orion Group Life Sciences are currently recruiting an Associate Quality Specialist on behalf of our Multinational Biopharmaceutical Client based in Tipperary on an initial 11-Month contract with potential to extend.

Hybrid role 3 days per week onsite.

Role Purpose
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 across site.
• 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.

 
Desirable

• 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.
• Exposure to lean / continuous improvement methodologies.

 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.