QA CAPA/ NCR Governance Engineer

Vantive

Castlebar

On-site

EUR 65,000 - 85,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Benefits offered by this job

Competitive salary

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 and global

Recognition and reward programmes

Inclusive and collaborative working

Job summary

Vantive in Ireland is seeking a QA NCR Governance Engineer to oversee Non-Conformance Reports and CAPA activities across the site, ensuring GMP compliance and accurate quality records.

The role requires tracking, trending, and reporting KPI targets, delivering training, and partnering with cross-functional teams to drive continuous improvements in quality management systems at our site in Castlebar.

Qualifications

Experience in Quality Assurance or Quality Systems within regulated manufacturing.
Experience in pharmaceutical/biotech/medical device sectors.
Strong written and verbal communication skills.

Responsibilities

Complete NCR and CAPA records per site procedures.
Track NCRs/CAPAs to closure within KPIs.
Conduct monthly NCR and exception trend analyses.
Report site Quality and QCR metrics.
Escalate issues to CRB as required.
Deliver training on NCR and CAPA management.

Skills

Quality assurance

GMP compliance

Documentation writing

Stakeholder management

Analytical problem solving

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

QA NCR Governance Engineer is responsible for the oversight and governance of Non-Conformance Reports (NCRs) and CAPA activities across the site. The role ensures quality records are effectively managed, KPI targets are achieved, and compliance with GMP and regulatory requirements is maintained.

Key Responsibilities

Complete NCR and CAPA records in line with site procedures and quality standards.
Track NCRs and CAPAs to closure, ensuring timelines and KPI targets are met.
Conduct monthly NCR and exception trending analysis and communicate findings.
Track and report site Quality and QCR metrics.
Perform adequacy reviews of NCR and CAPA records.
Escalate quality issues to the Corrective Review Board (CRB) as required.
Host CRB meetings and weekly CAPA update boards.
Serve as the site subject matter expert and point of contact for NCR and CAPA processes.
Deliver training and guidance on NCR and CAPA management.
Support continuous improvement initiatives within the Quality Management System.

Qualifications & Experience

Experience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.