Automation QA Specialist
Location: Full-time onsite | Raheen, Limerick, Ireland
Employment Type: Permanent
About the Company
Our 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 Responsibilities
1. 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.
Requirements
- BSc, 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.
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