NCR & CAPA Quality Governance Engineer

Vantive; Ireland; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Competitive salary and annual bonus opportunity

Pension scheme

Health and wellbeing programmes

Employee Assistance Programme (EAP)

Life assurance and income protection

Generous annual leave entitlement

Flexible working arrangements

Learning and development opportunities

Internal career progression

Recognition and reward programmes

Inclusive and collaborative working environment

Job summary

Vantive is seeking a QA NCR Governance Engineer in Ireland. This role involves oversight and governance of Non-Conformance Reports (NCRs) and CAPA activities, ensuring compliance with GMP and managing quality records. Ideal candidates will have experience within the pharmaceutical, biotechnology, or regulated manufacturing sectors.

The position offers a competitive salary, annual bonus opportunity, and a range of benefits including pension scheme, health programmes, and flexible working arrangements.

Qualifications

• Experience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• Experience in a Quality Assurance or Quality Systems role.
• Strong communication, organisational, and stakeholder management skills.
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities.

Responsibilities

• Complete NCR and CAPA records in line with site procedures.
• Track NCRs and CAPAs to closure.
• Conduct monthly NCR and exception trending analysis.
• Track and report site Quality and QCR metrics.
• Perform adequacy reviews of NCR and CAPA records.
• Escalate quality issues to the Corrective Review Board.
• Host CRB meetings and weekly CAPA update boards.
• Deliver training and guidance on NCR and CAPA management.
• Support continuous improvement initiatives.

Skills

Strong communication skills

Organisational skills

Stakeholder management

Technical writing

Analytical abilities

Problem-solving abilities

Education

Experience in Quality Assurance or Quality Systems

Experience in pharmaceutical or regulated manufacturing

Job description

Vantive is seeking a QA NCR Governance Engineer in Ireland. This role involves oversight and governance of Non-Conformance Reports (NCRs) and CAPA activities, ensuring compliance with GMP and managing quality records. Ideal candidates will have experience within the pharmaceutical, biotechnology, or regulated manufacturing sectors.

The position offers a competitive salary, annual bonus opportunity, and a range of benefits including pension scheme, health programmes, and flexible working arrangements.