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. Our 107,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Ireland Diagnostic Division – Longford:**
Abbott established a diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents.
In 2004, Abbott’s operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004, and the first product (Architect® TSH) was launched in December of 2005.
The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.
Abbott in Longford manufactures 18 diagnostic reagent products for thyroid function, fertility, and pregnancy, cardiology, renal and metabolic. Our products are manufactured to the highest standards of quality and are regulated by bodies such as the U.S. Food and Drug Administration and the International Organization for Standardization (ISO).
**PURPOSE OF THE JOB**
Manage and lead the Validation / Quality Engineering activities and associated team, ensuring related process, test method & FUE validations meet customer, division, regulatory and product quality requirements
+ Provide leadership and guidance on documentation and requirements of equipment/ facility/ utility qualification, test method validation, software validation / qualification and process validations in alignment with applicable global standards and regulatory requirements.
+ Implement and maintain of the validation and qualification systems at ADD Longford ensuring applicable internal and external requirements are met.
+ Plan, initiate and direct improvements to the validation/quality engineering area as needed to meet changing demands or requirements.
+ Provide training and development of personnel to ensure skills and talents are appropriate to meet the validation organization’s responsibilities.
+ Inform site management about quality related issues relating to validation requiring attention or improvement.
+ Support resource and budget requirements planning associated with validation related activities.
+ Ensure compliance to current Good Manufacturing Practices (cGMP).
+ Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well at the Abbott Global and Technical standards.
+ Application of appropriate and accurate validation / qualification strategies and associated documentation.
+ Validation related procedures and training implemented are in compliance with internal and external standards and regulatory requirements.
+ Ensure that the Validation/Quality Engineering team is closely aligned with the overall business goals.
**EDUCATION & COMPETENCIES**
+ Five years experience in a regulated industry, including demonstratable experience in a position with personnel responsibility is required as this will provide a good foundation for this job function.
+ Direct experience in Validation is a requirement for this role.
+ Degree level qualification in Natural Sciences, Life Sciences, Biotechnology, Quality Engineering or comparable area
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An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org