Pharma Quality Systems Specialist - eQMS & Compliance

Next Generation; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

Next Generation in Dublin, Ireland, seeks an experienced Quality Systems Specialist to lead eQMS improvements, drive regulatory compliance and strengthen QA processes in a fast-paced pharmaceutical environment.

You will own deviations, CAPAs, change controls, CSV validation, and quality metrics, collaborating with Quality, IT and manufacturing. Proficiency in TrackWise Digital and Power BI is highly valued.

Qualifications

• Bachelor's degree in Life Sciences, Biochemistry, Microbiology or related field.
• 5–7 years in Quality Assurance within pharma or regulated industry.
• Strong knowledge of QMS and regulatory requirements.
• Hands-on eQMS administration and governance.
• Experience with deviations, CAPAs, change controls and risk assessments.
• Knowledge of EU/FDA GMP, GDP and data integrity concepts.
• Experience with audits and inspection readiness.
• Experience with KPI reporting, data analysis and trend reporting.
• Experience with TrackWise Digital or similar eQMS and Power BI dashboards.

Responsibilities

• Manage and improve electronic Quality Management Systems (eQMS) to regulatory requirements.
• Provide SME in eQMS governance, configuration, access and workflows.
• Support deviations, CAPAs, change controls and risk assessments.
• Ensure GMP/GDP compliance and data integrity across systems.
• Contribute to CSV validation and lifecycle management of computerized systems.
• Collaborate with Quality, IT and cross-functional teams on system improvements.
• Monitor KPIs, dashboards and trend analyses for quality performance.
• Support audits, inspections and supplier quality reviews.
• Lead continuous improvement initiatives across Quality Systems and Operations.

Skills

Quality Assurance

QMS

eQMS

Power BI

Deviations & CAPAs

Data analysis

Regulatory compliance

Education

Bachelor's degree in Life Sciences or related field

Tools

Power BI

TrackWise Digital

eQMS software experience

Job description

Next Generation in Dublin, Ireland, seeks an experienced Quality Systems Specialist to lead eQMS improvements, drive regulatory compliance and strengthen QA processes in a fast-paced pharmaceutical environment.

You will own deviations, CAPAs, change controls, CSV validation, and quality metrics, collaborating with Quality, IT and manufacturing. Proficiency in TrackWise Digital and Power BI is highly valued.