Quality Engineer: GMP, Validation & Audits Lead

Exertis (UK) Ltd.; Galway; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Vital Healthcare in Galway invites a Quality Engineer to join our manufacturing site, delivering quality support and overseeing validations, monitoring and calibration activities to uphold GMP and EU requirements. You will develop, maintain and implement SOPs, Validation Protocols, Risk Assessments and technical files, while supporting regulatory inspections, customer audits and internal quality audits.

The role also drives continuous improvement across manufacturing, maintenance and quality

Qualifications

• Relevant third level qualification in science or quality
• Experience in a regulated manufacturing environment (GMP/GDP)
• Experience with EU IVDR/EU MDR and quality management systems (ISO 17025/9001/13485)
• Experience with risk management per ISO 14971 is preferable
• Experience supporting validation activities (IQ/OQ/PQ) and change management
• Demonstrated project management experience
• Auditor certification is an advantage

Responsibilities

• Provide quality support across site to ensure effective maintenance and implementation of the Quality management Systems.
• Ensure compliance to GMP, EU IVDR, and applicable regulatory requirements.
• Support regulatory inspections, customer audits, and internal quality audits.
• Develop, maintain, and ensure implementation of SOPs, Validation Protocols, Risk Assessments, and technical files.
• Support issues management (Complaints and Vigilance activities).
• Oversee and manage equipment qualification, validation and calibration activities to ensure GMP compliance.
• Oversee the operations of onsite monitoring systems.
• Perform quality assurance to ensure raw materials and finished products meet quality standards.
• Support site-level quality risk management and related documentation.
• Drive continuous improvements across manufacturing, maintenance and quality systems.
• Lead quality-related projects as assigned by Site Quality manager; deliver on time and within budget.

Skills

Regulatory compliance

GMP/GDP knowledge

Quality risk management (ISO 14971)

Project management

Auditing experience

Analytical thinking

Cross-department collaboration

Education

Bachelor's degree in science/quality

Tools

IQ/OQ/PQ validation

ISO management systems (ISO 17025/9001/13485)

Job description

Vital Healthcare in Galway invites a Quality Engineer to join our manufacturing site, delivering quality support and overseeing validations, monitoring and calibration activities to uphold GMP and EU requirements. You will develop, maintain and implement SOPs, Validation Protocols, Risk Assessments and technical files, while supporting regulatory inspections, customer audits and internal quality audits.

The role also drives continuous improvement across manufacturing, maintenance and quality