Quality Professional

Full Time
Longford, County Longford
Posted
Job description

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 over 5,000 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:
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.

Longford is based in the midlands of Ireland surrounded by water with the River Shannon, Lough Ree and the Royal Canal. It has a vibrant collection of communities with a rich historical background. The County has plenty to offer to both visitors and citizens in sport, culture, literature, amenities, festivals, events, retail and dining.

We currently have a position for Quality Professional in our Quality Department which will involve the following:

Primary Function:

Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, aligned to our standards, our procedures & the applicable regulations we are governed under.

Major Responsibilities:

  • General Area: Contributes to defining and timely achievement of overall business and proect goals. Provides compliant solutions to a variety of problems of moderate scope and complexity. Interacts constructively with peers, managers and cross-functional peers. May lead a project with a limited scope, but usually a contributor on broader projects. Provides guidance to other Professionals and Technicians. Scope typically limited to one specific QA function.
  • Quality System Compliance: Maintains awareness of standards and regulations that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
  • Risk Management: Applies basic to moderate Risk Management principles to work.
  • Problem Solving: Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions.

Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight. Decisions may have short- and long-term impact.

Depending on Functional Area

  • Risk Management: Participates in the development or modification of Risk management files.
  • Complaint Evaluation: Investigates complex complaints with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
  • Design Control / Documentation & Change Control: Identifies areas for process improvement.Provides supporting information for change including reasons and justifications.
  • Quality Engineer: Coordinates quality decisions between different quality and engineering groups.Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.
  • IQA Commodities: Supports the execution, review and approval of activities associated with this area, ensuring compliance to governing procedures. Executes IQA Commodity testing under cGLP conditions.
  • IQA Chemical/Biologics: Supports the execution, review and approval of activities associated with this area, ensuring compliance to governing procedures. Executes IQA Chemical/Biologics testing under cGLP conditions.

Education & Experience:

  • Apprenticeship or relevant third level qualification is required OR relevant combination of education or experience.
  • At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
  • Demonstrates understanding of how their function supports the business.
  • Demonstrates technical and business competencies that drive results and continuous improvement.

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