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.
The
QA In Process Engineer
evaluates the quality assurance of processes and products and recommends revisions of indicated specifications. In this role you will work closely with multiple teams including Production, Chemistry, Engineering, and other support functions.
Essential Duties & Responsibilities:
* 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
Key skills:
* 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.
What can Vantive offer to you:
* A stable and secure work environment
* A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
* A collaborative and dynamic work environment
* Access to state-of-the-art equipment and technology
* Recognition and reward for outstanding performance