QA In Process Engineer

Vantive; Castlebar; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus opportunity

Pension scheme

Health & wellbeing programmes

EAP

Job summary

Vantive is a vital organ therapy company focused on extending lives. We are seeking a QA In-Process Engineer to support quality assurance across manufacturing, review batch records, manage complaints, CAPA and process improvements.

You will collaborate with cross-functional teams, contribute to CAPA closure, and help maintain audit readiness in a dynamic, regulated environment. Hybrid working options available in Ireland.

Qualifications

• Experience in pharmaceutical/biotech/regulated manufacturing environments.
• Strong understanding of QA principles and GMP requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Review batch records and provide disposition recommendations.
• Support batch release activities per GMP requirements.
• Investigate product complaints and drive CAPA actions.
• Assist in SOPs and GMP documentation updates.
• Support audits and inspections and prepare quality reports.

Skills

QA & GMP knowledge

Quality systems

Communication skills

Problem solving

Cross-functional work

Technical writing

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.

As a QA In-Process Engineer, you will play a key role in supporting quality assurance activities across manufacturing operations. You will be responsible for batch record review, product complaint management, CAPA activities, process improvements, and supporting compliance and audit readiness.

Key Responsibilities

• Review executed production batch records and provide batch disposition recommendations.
• Support batch release activities in accordance with GMP and quality requirements.
• Manage and investigate product complaints, ensuring timely closure and effective resolution.
• Support CAPA activities and drive timely completion of quality actions.
• Review and prepare SOPs, work instructions, and other GMP documentation.
• Participate in the development and implementation of process improvement initiatives.
• Collaborate with cross-functional teams to resolve quality issues and improve operational performance.
• Manage assigned quality projects and contribute to site objectives.
• Support internal, customer, and regulatory audits and inspections.
• Prepare and present quality performance and management reports.
• Contribute to departmental KPI achievement and continuous improvement activities.

About You

• Experience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• Strong understanding of Quality Assurance principles and GMP requirements.
• Excellent communication and interpersonal skills.
• Strong problem-solving and critical-thinking abilities.
• Experience working effectively within cross-functional teams.
• Strong technical writing and documentation skills.
• Ability to manage multiple priorities and work independently.

You Will Be

• Accountable for delivering results.
• Innovative and solution-focused.
• Comfortable working in a dynamic environment with changing priorities.
• A team player with a strong customer and quality focus.Capable of influencing and collaborating across different functions.
• Passionate about continuous improvement and operational excellence.

Our Benefits

• Competitive salary
• Annual bonus opportunity
• Pension scheme
• Comprehensive health and wellbeing programmes
• Employee Assistance Programme (EAP)
• Life assurance and income protection
• Generous annual leave entitlement
• Flexible and hybrid working opportunities (role dependent)
• Learning and development programmes
• Career progression and internal mobility opportunities
• Recognition and reward programmes
• Inclusive and collaborative working culture
• Opportunity to make a meaningful impact on patients' lives worldwide

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process

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