Summary:
A Quality Systems Specialist is required for a biopharmaceutical company in Waterford. The successful candidate will support organisational transformation by simplifying and standardising processes, improving cycle times through performance and continuous improvement initiatives, and implementing risk-based approaches across Quality Continuous Improvement processes.
Responsibilities:
- Support the transition from paper-based to digital onsite.
- Focus on AI-driven tools to make better, data-driven decisions more quickly.
- Right first-time principle in the execution and delivery of all projects.
- Facilitating cross-functional teams to identify quality improvement opportunities and implement solutions
- Monitoring and analysing quality metrics to identify trends and areas for improvement
- Contributing to quality issues investigations to identify the underlying root cause and define the appropriate preventive actions
- Leading and managing continuous improvement projects using the appropriate methodologies
- Collaborating with production teams to implement process improvements
- Supporting the implementation of new quality systems and tools
- Measuring the effectiveness of improvement initiatives implemented and defining remediation action when necessary
- Maintaining records of improvement activities and reporting on their progress to stakeholders.
- Fostering a culture of continuous improvement within the organization
- Drive, develop, and maintain the CI Board under his/her scope.
- Establish and prioritize quality initiatives for the area in scope.
- Advise on best practices for quality management and continuous improvement.
- Advise production teams on process improvement strategies.
- Inform teams about best practices and their benefits.
Qualifications & Experience:
- Relevant degree in Science, Engineering, Quality, or a related discipline.
- 3+ years’ experience working in a Quality role within a GMP-regulated manufacturing environment.
- Experience working with Quality Management Systems (QMS).
- Experience supporting or leading Continuous Improvement initiatives, ideally within a GMP manufacturing environment preferred.
- Experience with quality investigations, root cause analysis and CAPA.
- Experience analysing quality metrics and data to identify trends and improvement opportunities.
