Automation QA SpecialistLocation: Full-time onsite | Raheen, Limerick, Ireland
Employment Type: Permanent
About the CompanyOur client, a global biopharma leader with a state-of-the-art manufacturing facility in Raheen, Limerick, is focused on delivering innovative therapies through cutting-edge bioprocessing technologies.
They are currently seeking a Senior Associate – Automation QA Representative to join the Quality Assurance team, supporting compliance and continuous improvement across computer systems in a GMP environment.
Key Responsibilities1.
Quality Assurance Oversight Develop and maintain QA procedures, policies, and systems for computerised systems.Conduct routine self-inspections and time-on-the-floor assessments to ensure cGMP compliance.Work closely with Automation, IT, and Manufacturing to support quality across all systems.Manage deviations, non-conformances, and CAPAs to drive quality standards.Participate in cross-site or cross-functional meetings to align QA standards for computer systems.2.
Regulatory Compliance Monitor industry regulations and ensure internal processes remain compliant.Support audit readiness and lead QA responses during inspections.Ensure compliance with change control, periodic reviews, data security, backup, and archive processes.3.
Documentation & Reporting Maintain accurate records including change controls, deviations, and QA documentation.Support alignment of local procedures with global standards for computer systems.4.
Continuous Improvement Identify opportunities to improve system quality and process efficiency.Contribute to risk assessments and QA improvement initiatives.5.
Training & Development Provide guidance and training on computer system QA to relevant staff.Keep up to date on new technologies and quality system requirements.RequirementsBSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.Minimum of 3 years' QA experience in a biotech, pharma, or medical device setting.Solid knowledge of cGMP, FDA regulations, Data Integrity, and Quality Risk Management.Strong problem-solving, documentation, and collaboration skills.Experience with QMS platforms (e.g.
TrackWise) and automation systems (e.g.
DeltaV, DCS) is an advantage.Proactive, detail-oriented, and comfortable working independently.#LI-DB4
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