Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Reporting to the In Projects QA Manager, the Quality Engineer is responsible for providing technical guidance and support to project teams implementing process improvement, new product introductions and other change programs in Castlebar & Swinford to ensure all activities are completed in compliance with Baxter and other GMP regulations.
Key elements of the job include:
1. Working within Validation/QA group on the preparation and execution of protocols for facility, equipment, new product introductions, software and process validation.
2. Act as an active team member on selected process & product improvement programs.
3. Interpret and implement Baxter and GMP requirements associated with the process, change control and validation requirements.
4. Standardise systems, procedures and practices relating to the implementation of technical requirements.
5. Act as Quality Assurance approver of project plans and reports.
6. Prepare and defend validation strategy to regulatory agencies.
7. Ensure Baxter change control requirements are implemented.
8. Provide technical advice to the project teams and obtain other technical input as required
9. Approve updated manufacturing and quality procedures.
10. Confirm GMP compliance following project completion
11. Responsibility for ensuring that manufacturing operations are maintaining product quality standards.
12. Ensuring that corrective action is taken to prevent re-occurrence of problems.
13. May perform other duties as assigned