QA In Process Engineer

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 In Process Engineer

We are actively searching for QA in Process Engineer to join our team of wonderful people based in our Castlebar, Co. Mayo sites. The Castlebar and Swinford facilities employ more than 1400 staff, and we operate 24/7. 

You will work closely with multiple teams including Production, Chemistry, Engineering, and other support functions.

What you will be doing:

• Achieve/Improve department KPIs & support plant goals with limited supervision
• Review executed production batch records and provide deviation/batch dispositions
• Investigate customer complaints ensuring that each complaint is addressed and closed in a timely manner
• Ensure each NCR/deviation is investigated and documented and that appropriate corrective actions have been developed and implemented in a timely manner
• Support process improvements
• Regularly makes decisions which impact quality, time and/ or cost
• Review and prepare SOPs, work instructions and other GMP documents
• Proactively work within cross functional teams to address quality issue
• Manage assigned projects and work within cross functionally teams
• Support regulatory and compliance audits
• Prepare and present quality management reports

We are looking for someone that has:

• Takes accountability for results
• Innovates and drives for solutions
• Ability to deal with ambiguity
• Critical thinking & problem-solving skills
• Team player and customer / results oriented
• Ability to meet deadlines and effectively deal with workload
• Ability to accurately communicate ideas, facts and technical information
• Membership of a professional body desirable

 Experience required:

• Minimum of 2 years industrial experience in a QA role preferably in a pharmaceutical or Healthcare environment.

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, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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