Vantive: A New Legacy
Baxter is on a journey to separate our $5 billion 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.
At Vantive, you will join a community of people who are focused, courageous and driven to improve patients' lives worldwide. We believe Vantive will not only build leadership in the kidney care space, it will also offer meaningful work.
Your Role:
This position has tremendous potential for growth. We're searching for a Documentation/ Labelling Specialist to join our team based in Castlebar, Co. Mayo.
As a member of our Quality team, you will maintain high-level documentation and labelling management and implement improvements across sites.
Responsibilities:
* Manage new/revised labeling in line with marketing and regulatory compliance.
* Print production labels as required.
* Follow procedures to maintain serialisation labelling requirements.
* Process and Issue specification/ procedure changes for the site.
* Coordinate archiving of documents.
* Update Batch record parameters per procedures.
* Closure of Validation protocols on Baxter Validation Data base (VMS).
* Maintain current versions and labeling databases.
* Route Labelling and associated documentation on Baxter documentation system Teamcenter (TCU).
* Identify, develop and implement best practices of the Label/ Documentation Control Function.
* Responsible for purchasing of labeling and documentation department items.
We are looking for:
* Bachelor's degree or equivalent.
* Graphic Art experience (not essential).
* Ensures accountability and plans commitments and is deadline driven.
* Strong computer skills – Microsoft Office and Adobe Acrobat.
* Familiar with FDA regulations, GMP's and standard operating procedures.
* Experience with computerized proofreading systems.
* Strong written and verbal communication skills.
* Strong attention to detail.
Benefits:
* Pension.
* Annual Bonus.
* Health Insurance.
* 25 Days Holidays.
* Life Assurance.