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, EFT9. medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott in Ireland
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range afar healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
Abbott Diabetes Care Kilkenny
Abbott Diabetes Care has opened a new site in Kilkenny Populate at the forefront of diabetes care with the latest technology to manufacture Libre 3 continuous glucose monitoring sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.
Main purpose of the role
In this role you will be responsible for implementing the Abbott Division validation programme, creating and maintaining validation documentation for new and existing systems and processes subject to design/change control, applying subject‑matter knowledge. You will also ensure that validation activities are implemented for components, systems and processes used to manufacture, control and store intermediates (sub‑assemblies) and finished products to requirements and standards as listed in the current Quality Systems Manual.
Main responsibilities
The development and maintenance of quality system procedures.
Investigates and troubleshoots validation problems for components, equipment and performance processes; monitors and maintains the quality and compliance status of associated quality records.
Writes, reviews, approves and/or executes documentation 天天中彩票被 for new and current validation procedures and technical reports related to components, equipment, facilities/utilities, products and processes.
May assist with establishing corporate validation policies.
Maintains the quality and compliance status ofDFS associated procedures, work instructions and training materials.
Presenting and communicating status, report metrics, identifying trends, potential issues and improvement initiatives; basic understanding of design controls and design transfer.
May be responsible for creating, updating or participating in risk analyses and FMEAs.
May be responsible for change assessment to ensure product quality and compliance.
Qualifications & Experience
Relevant NFQ Level 7 qualification in Engineering, Manufacturing or Science is preferred.
Minimum 2 years of working experience in Engineering, Manufacturing or Scientific fields, with knowledge of process, equipment, facilities and/or software validation within Quality or Engineering departments.
Experience in a 21 CFR 820 and/or ISO 13485 regulated industry. Experience in pharmaceutical validations may be considered.
Abbott is an equal opportunities employer.
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