External QA Associate: Shape Global Quality Systems

Tandem Project Management Ltd.; Cork; On-site; EUR 42,000 - 62,000; Full time

Job summary

Tandem Project Management Ltd. in Cork is seeking an External QA Associate to support the External Quality Systems programme and drive continuous improvement of Quality Management Systems.

You will ensure deviations, CAPAs, change controls and governance activities are managed in compliance with regulatory requirements. The role involves coordinating cross-functional meetings, developing quality metrics, and contributing to global quality alignment while delivering training and supporting

Qualifications

• Bachelor’s degree in Science, Engineering, Quality, Pharmaceutical Sciences or related discipline.
• Minimum of 1 year’s experience within biopharmaceutical, pharmaceutical, medical device or another regulated industry.
• Experience in Quality Assurance, Compliance, Regulatory Affairs, Manufacturing Quality or a related function.
• Practical knowledge of Quality Management Systems and regulated quality processes.
• Experience with deviations, CAPAs, change controls, audits, inspections or quality governance activities would be advantageous.
• Experience with quality metrics, performance reporting, data analysis or data visualisation.
• Experience with Power BI, Power Automate, Microsoft Copilot, SharePoint, Microsoft Lists, Power Apps or equivalent digital tools would be advantageous.

Responsibilities

• Review Quality Systems metrics to support timely closure of quality records.
• Coordinate cross-functional meetings focusing on deviations, CAPAs and change controls.
• Develop and report quality metrics for standardisation across the organisation.
• Coordinate monthly quality governance meetings and prepare updates/reports.
• Support digital improvement initiatives within External Quality.
• Deliver training on Quality Management Systems as required.
• Partner with global Quality Systems teams to support consistent application of QMS.
• Identify and implement continuous improvement opportunities across External Quality systems.

Skills

Quality Assurance

Regulatory Affairs

Data analysis

Change controls

Audits

Education

Bachelor's degree in Science, Engineering, Quality, Pharmaceutical Sciences or related

Tools

Power BI

Power Automate

Microsoft Copilot

SharePoint

Microsoft Lists

Power Apps

Job description

Tandem Project Management Ltd. in Cork is seeking an External QA Associate to support the External Quality Systems programme and drive continuous improvement of Quality Management Systems.

You will ensure deviations, CAPAs, change controls and governance activities are managed in compliance with regulatory requirements. The role involves coordinating cross-functional meetings, developing quality metrics, and contributing to global quality alignment while delivering training and supporting