About AbbottAbbott 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 109,000 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. In Ireland, Abbott employs around 6,000 people across ten 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 Nutrition Division Cootehill CavanAbbott Nutrition produces a range of infant formulae in all pack sizes under the brand name “Similac.” To complement the range of “Similac” infant formulae, the facility also manufactures a range of follow-on formulae under the brand name of “Gain.” The essential ingredient is liquid skim milk, which is combined with carbohydrate, vegetable oils, vitamins, and minerals. The product is blended, pasteurized, dried, and packaged at the site and once packaged, is distributed to Europe, South East Asia, the Middle East, Latin America, and Canada.Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility, which processes 500,000 litres per day. This secure supply together with Ireland’s reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.PURPOSE OF THE ROLEProvide direction, documentation, execution, and review for PoP / Unexpected events, QualEx metrics, Executive Management Review, Quality Management Review, Human Reliability Program (HRP), Cost of Quality, and Continuous Improvement.Work closely with the CAPA and Validation Manager.Provide leadership across a number of site functions including Quality Excellence, PoP / Unexpected events, and HRP.KEY RESPONSIBILITIESThe Quality Excellence and PoP Site Lead will be part of the QA Team reporting to the CAPA & Validation Manager.Manage and coordinate the Quality Excellence (QualEx) metrics on site. Track QualEx metric performance and progress against targets on an ongoing basis.Timely submission of QualEx metrics & associated commentary for QA dept.Track QualEx performance and progress against QualEx milestones.Manage and coordinate the site QA wall/boards. Update the wall for unexpected and PoP events and supply QA weekly key takeaways.Provide QA site status and QualEx Metrics Update at Tier 3 meetings.Manage and coordinate the QA slides for the Executive Management Review. Verify that metrics and commentary are correct and ensure consistency of information.Manage, coordinate, and prepare the Quality Management Review slide deck, liaising with personnel from respective departments. Verify that metrics and commentary are correct and ensure consistency of information. Chair and present the Quality Management Review and maintain minutes of the meeting in a timely manner.Coordinate the PoP / Food Safety teams as a governing member of the Food Safety Board (FSB).Attend all AN Division monthly PoP workstream meetings.Analyze PoP signals and events. Identify trends, where applicable. Assist in the coordination of appropriate actions to be taken (e.g. Bracketing, Containment, Root Cause Analysis (RCA), and Corrective Actions / Preventive Actions (CAPA)).Prepare and present the PoP / Food Safety monthly meeting to the FSB. Identify actions complete, improvements pending, PoP Gold star criteria ratings, status to workstream targets, and identify trends. Liaise with other AN sites to determine ‘Best in Class’.Lead the Human Reliability Program (HRP) on site from a Quality perspective. Educate key site personnel on HRP.Conduct compliance audits and walk-downs and complete necessary follow-up reports and also participate in internal audits.Lead Cost of Quality within the QA Department, liaising with applicable QA members to determine opportunities.Lead and facilitate Continuous Improvement within the QA Department, liaising with applicable QA members to determine and support opportunities.Lead and facilitate OpEx Improvement / maturity within the QA Department, liaising with applicable QA members to determine and support opportunities.Coordinate and communicate identified quality-related news via the Qualitweet forum.This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises.Support QA team with internal and external audits (including pre-audit preparation) surrounding the Quality Management Review processes.EDUCATION AND COMPETENCIES REQUIREDBachelor’s Degree in Pharmaceutical Science, Food Science, Dairy Science, or related Engineering qualifications. Food Microbiology or Food Chemistry would be desirable; however, not essential.It is an advantage to have knowledge of HRP and CAPA.Food Engineering, thermal heat processing, and fluid flow are advantageous.Knowledge of the nutritional industry preferred.Project Management Skills or experience with Project Management is essential.Excellent interpersonal skills and very good computer literacy.Ability to work as an effective member of a high-performance team.
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