About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. We serve people in over 160 countries.
Abbott in Ireland
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices, and nutritional products. In Ireland, we currently employ approximately 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford, and Sligo.
Abbott Ireland Diabetes Care Division Donegal
The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among our leading brands are the FreeStyle Precision, FreeStyle Lite, and FreeStyle Libre system.
Primary Function:
The Quality Batch reviewer is primarily responsible for the product realization process (Review, approval, and closure of in-process and Final lot release for both BGM and Libre sensor) in addition to supporting other departments to meet timelines and shipments thereby ensuring the site delivers safe and effective products while maintaining compliance with ADC policies and procedures.
Responsibilities Include:
* Review and maintenance of BGM Device History Records.
* Review and approval of BGM final product inspection sheets for product release.
* Closure of Libre in-process & Final lots for product release.
* Responsible for working with Department Leads/Engineers to ensure any issues are addressed to progress the lots to final release (BGM & Libre).
* Performing tasks on computerized systems in order to release lots - SAP, POMs, Trackwise, and Sharepoint.
* Supporting Technical and Operation Engineering to meet validation timelines in review of Validation Batch records.
* Generating DHR review forms for Libre complaint lots.
* Responsible for the close out of MT (material transfer) forms on POMs.
* Tracking DHR review metrics to ensure site targets are met.
* Other tasks and duties as assigned.
Education and Years Experience:
* Second Level Qualification.
* Minimum 2 years' experience in Manufacturing environment.
* Proficient in the use of Microsoft Word, Excel & PowerPoint.
* Self-motivated, good attention to detail, and works well under pressure.
* Previous knowledge of BGM/Libre production process is desirable.
Accountability/Scope:
The role reports to the Batch review Team Lead.
Day Shift.