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 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 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 Nutrition Sligo

We understand that proper nutrition is the foundation for living the best life possible. That’s why we develop science-based nutrition products for people of all ages. Our products help babies and children grow, keep bodies strong and active, and support the unique nutrition needs of people with chronic illnesses — to make every stage of life a healthy one.

Abbott is a leader in providing enteral nutrition feeding devices, including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs.

PURPOSE OF THE JOB:

As Portfolio expansion Quality Professional, you will be reporting to the Quality Manager for International Portfolio Expansion within Abbott Nutrition organisation.  The role will have responsibility for the continuous improvement and execution of the start-up project QA activities while maintaining compliance with all applicable Quality system standards and regulations as well as Abbott policies and procedures.

MAJOR RESPONSIBILITIES:

• Initiation of robust long-term working quality relationships with new third party manufacturers
• Provide necessary training to the Third-Party Manufacturing team on Abbott Expectations.
• Participate in Site Assessment or Site Qualification Audit preparation, conducting audit and follow-up on Corrective actions.
• Negotiate with Third Party Manufacturer on Quality Agreement.
• Integration of Abbott’s expectations and requirements into the Third-Party Manufacturers procedures in compliance within the Abbott quality system
• Ensure accurate documentations are provided on timely basis for Product registrations.
• Provide metrics for management review meetings, monthly reports etc.  Provide recommendations for improvement based on interpretation of data.   
• Ensure project QA activities are documented. (e.g. Non-Conformances, Deviations and Quality Assessments, to division and global policies.)
• Using problem solving tools, conduct and support investigations as they arise from manufacturing events and product complaints ensuring root cause is determined and appropriate CAPA actions implemented.
• Ensure compliance of quality system documents including, and procedures using established tools including Rubric.
• Liaise with various functions / departments within Abbott and coordinate activity with the manufacturer on behalf of regulatory, R&D, procurement, package engineering, and many more internal stakeholders.    

SUPERVISORY/MANAGEMENT RESPONSIBILITIES:

• The position has no direct reports however the role has the potential to evolve into a leadership role as the business continues to grow and evolve. 
• The position will require establishing close working relationships with both internal TPM QA and Operations Managers and external groups. 

EHS RESPONSIBILITIES:

• Ensure Environmental Health & Safety procedures are adhered to.
• Active participation and support of Abbott’s EHS programs
• Attend EHS training assigned.
• Report any H&S incidents, spills, releases to the environment and near misses. Support any corrective actions.

EDUCATION & COMPETENCIES:

• Bachelor’s Degree in a Science, or Food related discipline. 

• A minimum of 5 years relevant work experience at least 3 years in Science based company preferrable Nutrition or Dairy Industry with practical knowledge of project management.
• Excellent understanding of Food safety with previous experience in a Quality auditor role a distinct advantage.
• Excellent understanding of Quality Assurance principles.
• Thorough knowledge of manufacturing processes (spray dryer, Aseptic and Retort technology) is a plus.
• Excellent problem-solving and technical writing skills with experience in the use of problem-solving tools.
• Excellent communication and presentation skills.
• Excellent attention to detail and accuracy.
• Innovative and Continuous Improvement mindset.
• Certified Green belt in lean / six sigma would be advantage.
• Experience within a Global, multi-cultural organisation.

ACCOUNTABILITY/SCOPE:

• The position impacts directly on start-up and maintenance of Third-Party Manufacturing site; thus the Project timeline, Product Quality and Financial and Regulatory exposure of decisions could be significant.

• The position has scope for decision making within confines of agreed responsibilities. Activities broadly defined by agreed goals. Supervision is received through meetings and one on one meeting with the QA Manager startup. Periodic goal reviews, annual performance and career development reviews will also occur.

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