Documentation Labeling Specialist
Baxter
- Castlebar, Co Mayo
- Permanent
- Full-time
- Your role at Baxter:
We’re searching for a Documentation/ Labelling Specialist to join our team based in Castlebar, Co. Mayo.
As a member of our Quality team, the Documentation/ Labelling Specialist is responsible for maintaining a high level of documentation and labelling management and implement improvements across Castlebar and Swinford sites.
You will play a key part in the quality and compliance procedures which are critical to saving and sustaining lives. You will collaborate with many other departments and teams across both Swinford and Castlebar sites.
Join us and our culture of great teams whose work values include speed, simplicity, courage and collaboration.What are your responsibilities? * Responsible for management of new/revised labeling in line with marketing and regulatory compliance and complete all activities required for labelling updates.
- Printing of production labels as required
- Follow procedures to maintain serialisation labelling requirements as applicable.
- Process and Issue specification/ procedure changes for the site as required
- Coordinate archiving of documents
- Update Batch record parameters per procedures ( Ebatch wrappers)
- Closure of Validation protocols on Baxter Validation Data base ( VMS)
- Follow procedures to maintain current versions and labeling databases (Codesoft, Easi label, Ebatch/ Prism).
- Follow procedures to maintain current Bill of Material (Prism, Ebatch, EXPS).
- Route Labelling and associated documentation on Baxter documentation system Teamcenter (TCU).
- Identify, develop and implement best practices of the Label/ Documentation Control Function as appropriate to improve efficiency.
- Responsible for purchasing of labeling and documentation department items on Coupa.
- Perform other duties as assigned by business needs.
- Graphic Art experience ( not essential)
- Ensures accountability and plans and prioritizes 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, documentation, product lifestyle systems, Serialisation systems, digitized artwork storage and documentation system
- Strong written and verbal communication skills
- Strong attention to detail
- Willingness to work flexible hours
- Annual Bonus
- Health Insurance
- 25 Days Holidays