External QA Associate

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

We currently have an opportunity for an External QA Associate to join a leading biopharmaceutical organisation in Cork. The successful candidate will support the External Quality Systems programme, ensuring key quality processes, including deviations, CAPAs, change controls and quality oversight, are consistently managed in compliance with applicable regulatory requirements. The role will also support quality metrics, governance activities, digital improvement initiatives and the continuous improvement of Quality Management Systems.

Responsibilities:

• Review Quality Systems metrics and trends to support the timely closure of quality records.
• Coordinate cross-functional meetings focused on deviations, CAPAs and change controls, ensuring actions are progressed and completed on time.
• Develop and report quality metrics, supporting their standardisation across the organisation.
• Coordinate monthly quality governance meetings and prepare relevant updates and reports.
• Support the development and implementation of digital improvement initiatives within External Quality.
• Deliver training on Quality Management Systems, as required.
• Partner with global Quality Systems teams and cross-functional stakeholders to support the consistent application of the Quality Management System.
• Identify and implement continuous improvement opportunities across External Quality systems and processes.
• Participate in change control activities relating to qualified systems.
• Support internal audits, regulatory inspections and the External Quality Self-Inspection Programme.
• Contribute to global quality alignment and standardisation projects.
• Undertake other duties appropriate to the position, as required.

Qualifications & Experience:

• Bachelor’s degree in Science, Engineering, Quality, Pharmaceutical Sciences or a related discipline.
• Minimum of 1 years’ experience within the 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 supporting 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.