Quality System Specialist

Tandem Project Management Ltd.; Waterford; On-site; EUR 55,000 - 75,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a Quality Systems Specialist for a biopharmaceutical site in Waterford. You will support organisational transformation by simplifying and standardising processes and driving continuous improvement across Quality Compliance.

You will lead quality investigations, CAPA, and data-driven improvements, work with GMP systems, and help ensure right-first-time execution while partnering with production teams on process enhancements and risk-based decision making.

Qualifications

• Degree in Science, Engineering, Quality, or a related discipline.
• 3+ years’ experience in a GMP-regulated manufacturing quality role.
• Experience with Quality Management Systems (QMS).
• Experience supporting or leading Continuous Improvement initiatives in GMP manufacturing.

Responsibilities

• Support the transition from paper-based to digital onsite systems.
• Focus on AI-driven tools to enable data-driven decisions more quickly.
• Lead continuous improvement projects using GMP methodologies.
• Collaborate with production teams to implement process improvements.
• Support quality investigations, root cause analysis and CAPA.
• Monitor and analyse quality metrics to identify trends and opportunities.
• Foster a culture of continuous improvement within the organization.

Skills

Quality management

Continuous improvement

Root cause analysis

CAPA

Data analysis

Education

Degree in Science/Engineering/Quality

Tools

QMS

Job description

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.