Quality Systems Engineer

A Quality Systems Engineer is required for a leading pharmaceutical Company based in Waterford . This is a 12-month contracting position. If you are interested in transitioning the clients Quality system from paper-based processes to digital solutions, while exploring the use of AI-driven tools and data analytics then this is the position for you

• Lead and facilitate Continuous Improvement projects across Quality and Production.
• Work with cross-functional teams to identify opportunities for process optimisation and quality improvement.
• Monitor and analyse quality metrics and performance data to identify trends, risks and improvement opportunities.
• Support quality investigations, applying structured problem-solving and root-cause analysis techniques.
• Define and implement appropriate corrective and preventive actions.
• Support the introduction and adoption of new quality systems, digital tools and technologies.
• Contribute to the digital transformation of Quality processes, including the transition away from paper-based systems.
• Explore and support the implementation of AI and data-driven solutions to improve decision making and process performance.
• Measure the effectiveness and sustainability of improvement initiatives and identify further remediation where required.
• Maintain accurate records of CI activities and communicate progress, outcomes and benefits to key stakeholders.
• Share best practices and promote the benefits of Continuous Improvement across the organisation.
• Act as a trusted advisor to Production and Quality teams on process improvement and quality management best practice.
• Champion the Right First-Time principle across project execution and delivery.
• Operate in accordance with the SMS 2.0 CI Specialist role definition and standards.

• Degree Qualification in a Scientific background3-5 years experience within a GMP manufacturing / pharmaceutical companyExperience leading or facilitating Continuous Improvement projects.
• Experience using quality and performance data to identify trends and improvement opportunities.
• Knowledge of structured root cause analysis and problem solving methodologies.
• A strong understanding of Quality Management principles.
• A proactive approach to identifying and delivering improvements.
• An interest in digital transformation, AI and data-driven solutions.
• A strong commitment to quality and the Right First-Time philosophy