Quality Systems Specialist

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

Quality Systems Manager – Pharmaceutical

Location: Dublin, Ireland

Contract: 12–14 Months (Maternity Cover)

Role Overview

Ready to make an impact and drive quality systems excellence?

We are seeking an experienced Quality Systems Specialist to join a dynamic pharmaceutical organisation, taking a key role in enhancing quality systems, driving eQMS improvements and strengthening regulatory compliance.

This is an excellent opportunity to take ownership of critical quality processes, collaborate with cross-functional teams and contribute to continuous improvement within a highly regulated pharmaceutical environment.

Key Responsibilities

• Manage, maintain and continuously improve electronic Quality Management Systems (eQMS) in accordance with regulatory requirements and internal procedures.


• Provide subject matter expertise in eQMS administration, governance, system configuration, user access and workflow management.


• Manage and support deviations, CAPAs, change controls and quality risk assessments.


• Ensure compliance with GMP, GDP, data integrity and applicable regulatory requirements.


• Support computerised system validation (CSV), including validation documentation, system testing and lifecycle management.


• Collaborate with Quality, IT and cross-functional teams on eQMS enhancements, upgrades and system improvements.


• Monitor quality performance through KPIs, metrics, dashboards and trend analysis.


• Support the development and maintenance of Power BI quality dashboards and reporting.


• Maintain inspection readiness and participate in internal, supplier, customer and regulatory audits.


• Support supplier qualification, service provider oversight and periodic quality reviews.


• Review quality documentation and support batch acceptance and product disposition activities when required.


• Lead and contribute to continuous improvement initiatives across Quality Systems and Quality Operations.

Requirements

• Bachelor's degree in Life Sciences, Biochemistry, Microbiology or a related scientific discipline.


• Minimum 5–7 years' experience in Quality Assurance within the pharmaceutical or a similarly regulated industry.


• Strong knowledge of Quality Management Systems (QMS) and pharmaceutical regulatory requirements.


• Hands-on experience administering and maintaining an electronic Quality Management System (eQMS).


• Experience managing deviations, CAPAs, change controls and quality risk assessments.


• Good understanding of EU/FDA GMP and/or GDP regulations.


• Knowledge of data integrity, GAMP 5 and EU GMP Annex 11 principles.


• Experience supporting audits, regulatory inspections and inspection readiness activities.


• Experience with quality metrics, KPI reporting, data analysis and trending.


• Knowledge of computerised system validation (CSV) and GxP system lifecycle management.


• Experience with supplier qualification, supplier oversight and quality documentation.


• Excellent organisational, communication and problem-solving skills, with the ability to manage multiple priorities.


• Experience with TrackWise Digital or similar eQMS platforms.


• Experience using Power BI for quality dashboards and reporting.


• Strong understanding of document management and training management systems.


• Experience supporting eQMS configuration, workflow improvements and system upgrades.