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 around 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Kilkenny 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
- The CAPA Specialist will report to the CAPA & Validation Manager.
- Conduct weekly or more frequent CAPA meetings to track timelines and quality of Quality Records (QRs) and associated actions.
- Provide Leadership and support on the Corrective and Preventative Action System to all plant personnel.
- Report on monthly metrics with regard to CAPA and QRs.
- Ensure that all appropriate site Quality CAPA metrics are recorded and verified.
- Provide training to site subject matter experts and plant with regard to CAPA requirements as guided by division/corporate where required.
- Review site QRs to ensure compliance to Rubric requirements and associated site and division policy requirements.
- Collate CAPA information for site management review and area tier 3 information.
- Provide guidance in management of unexpected manufacturing events, required bracketing and containment and associated sampling if required.
- Complete Global CAPA review for impact to Cootehill site and support elevation process for site issues as required post QR approval.
- Support the QA CAPA IT System (ABTRAQ) through which investigations and CAPA's are documented. This also involves the development and support of plant SME's and general users.
- Liaise with other plant CAPA Specialists in Community of Practice meetings to address global concerns on CAPA opportunities/systems.
- Food Safety Team member – actively participating in Food Safety Team meetings, as required.
- Participate in internal audits and compliance walkdowns.
- Complete related projects as required.
- This Job function will change where updates to 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 where this need arises.
- Support QA team in other responsibilities/projects as required and when the need arises.
- Support QA team with internal and external audits (including pre-audit preparation) surrounding the CAPA Process.
- 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 function has the responsibility 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.
Major Responsibilities
- The CAPA Specialist will review all Quality Records (QRs). Will provide leadership and direction for QR initiation and root cause analysis.
- The CAPA Specialist shall ensure that site Quality CAPA Metrics are recorded and reported as needed.
Education Required
- A Diploma/Degree level education – science/engineering qualification an advantage.
Knowledge
- At least three years manufacturing experience in a quality assurance function within a regulated environment.
- Excellent interpersonal skills and very good computer literacy.
- Ability to work as an effective member of a high performance team.
Accountability / Scope
- This function will have the responsibility to ensure that Quality Records (QRs) are completed and that leadership and direction for QR initiation and root cause are complete. Will ensure that monthly Metrics are recorded and reported out as required. The impact of ineffective reporting may have implications on plant operations and compliance requirements.
Connect with us atwww.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook atwww.facebook.com/Abbottand on Twitter @AbbottNews.
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