External QA Quality Associate

Fastnet; Cork; On-site; EUR 42,000 - 54,000; Full time

Job summary

Fastnet is seeking a Quality professional on a 12-month contract to support External Quality Systems and drive digitalisation across Quality processes. The role focuses on improving governance, CAPAs, deviations, change controls and risk management.

You will analyse quality metrics, develop dashboards, and collaborate with cross-functional teams to enable data-driven decision-making. Experience in a regulated biopharma environment is required.

Qualifications

• 1+ years’ experience within a regulated biopharma, pharmaceutical or medical device environment.
• Experience with Quality Systems/QMS, with an interest in data, digital tools, process improvement and automation.
• Demonstrated ability to support external quality systems and drive digitalisation.

Responsibilities

• Support key Quality Systems, including deviations, CAPAs, change controls, risk management and Quality governance.
• Support audit and inspection readiness, self-inspections, training and ongoing compliance activities.
• Analyse Quality metrics and trends, developing dashboards and reporting to support effective decision-making.
• Identify opportunities to simplify and automate Quality processes using digital tools such as Power BI, Power Automate, SharePoint and Microsoft Copilot.

Skills

Data analysis

Automation interest

Education

Degree in Science, Engineering, Quality, Pharmaceutical Sciences or related discipline

Tools

Power BI

Power Automate

SharePoint

Microsoft Copilot

Job description

An exciting opportunity for a Quality professional to join a leading biopharma organisation, on a 12 month contract, supporting External Quality Systems while helping drive digitalisation and continuous improvement across Quality processes.

Key Responsibilities:

• Support key Quality Systems, including deviations, CAPAs, change controls, risk management and Quality governance.
• Support audit and inspection readiness, self-inspections, training and ongoing compliance activities.
• Analyse Quality metrics and trends, developing dashboards and reporting to support effective decision-making.
• Identify opportunities to simplify and automate Quality processes using digital tools such as Power BI, Power Automate, SharePoint and Microsoft Copilot.

Requirements:

• Degree in Science, Engineering, Quality, Pharmaceutical Sciences or a related discipline.
• 1+ years’ experience within a regulated biopharma, pharmaceutical or medical device environment.
• Experience with Quality Systems/QMS, with an interest in data, digital tools, process improvement and automation.