24-month FTC **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. Our 113,000 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 about 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 Cavan** Abbott 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 and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, 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. **Primary Function / Goals / Objectives** + Follow all Environmental, Health and Safety Rules and Regulations in the plant. + Report any current or potential hazards to your manager immediately. + Wear the correct Personal Protective Equipment (P.P.E.) at all times. Consult the appropriate SOP where required. + This manager is responsible for reviewing all SOP’s for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP. + Manage and lead a team consisting of CAPA and Validation Engineers. Ensure resources are managed appropriately and in accordance with Abbott and legislative standards. + The CAPA manager will lead investigations involving High Impact ER’s and work closely with plant SME’s to ensure a thorough investigation is carried out identifying root cause. + This function must ensure preventative actions put in place are effective and effectivity reports reviewed and tracked accordingly. + The CAPA manager must maintain and report monthly metrics to the plant with regard to plant Quality metrics. + The function leads the Monthly and Quarterly Management Review and ensures all information in tracked and collated accordingly for an effective forum. + Responsible for leading the weekly QA/CAPA meeting and ensuring all SME’s are engaged in the CAPA process. + This function will maintain very good communication with Division and Corporate colleagues. + The role will identify and develop were necessary appropriate training for the facilities with regard to CAPA systems. + This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP’s are made. + This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises. **Major Responsibilities** + Responsible for the overall CAPA management system for the Cootehill facility. Ensure resources are identified to ensure accurate and timely reporting of metrics. + This function plays a key role in investigation of high impact ER’s to ensure thorough investigation and root cause is identified. **Supervisory/Management Responsibilities** + The CAPA and Validation Manager has responsibility for the supervision of the Validation Engineer and the CAPA & Metrics Specialist in the Quality Department. + Additionally the position will require a managerial role in the following areas: + Contacts with all levels of management within the plant. + Contacts with Abbott personnel in other affiliates especially in Quality, Engineering,Regulatory, Technical, Manufacturing, and Materials. This role plays are vital role in leading the department managers and SME’s to ensure a strong and effective system exists. **Education Required** + A Bachelor of Food Science/Chemistry/Quality or a Third level qualification in a related discipline. **Knowledge** + Very good understanding of the manufacturing process. + Strong knowledge and experience in analytical techniques and methods used. + Excellent interpersonal skills and management skills. + Ability to: + Communicate with all levels of the organization. + Communicate effectively with cross-functional team. + Recognize and reward effort. + Resolve conflict constructively. + Seek feedback. **Accountability / Scope** + This function will have responsibility to ensure the CAPA system is managed effectively and all plant investigations are carried out fully and appropriately. The impact of ineffective reporting may have implications on plant operations and quality of Abbott product. 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 corpjat@abbott.com