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Quality Professional

3 months ago


Sligo, Ireland Abbott Full time

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 Diagnostic Division Sligo

Abbott Diagnostic's is a global leader of in vitro diagnostics with approximately 70,000 institutional customers in more than 100 countries. Our diagnostic products offer a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.

Abbott’s diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.

The role of Quality Professional will involve the following:

MAJOR RESPONSIBILITIES:

General Area : Contributes to defining and timely achievement of overall project goals. Provides compliant solutions to a variety of problems of moderate scope and complexity. Interacts constructively with employees, 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 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.

EHS : Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager. Ensure Environmental procedures e.g. recycling, waste minimization are adhered to and improvements made where possible.

Design Control / Documentation & Change Control: Assist initiators of change control documentation, including change plans, design plans and change requests (as required) to aid in the implementation of change. Reviews and approves changes to QSR and DMR documentation as required. Initiates site Change Plan and Document Change Request activities (as required) for changes identified through Product / Process improvement,Transfer activities and/or Identified compliance issues. Co-ordinate and manage Change Plan and Document Change Requests through to closure, including tracking of identified deliverables and action items. Work in conjunction with relevant Document/ Process owners to identify and organize CFTs. Identifies areas for process improvement. Attends process community meetings.

EDUCATION & COMPETENCIES:

A relevant third level qualification

At least 18months work experience in Quality or related field experience;

Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.

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.

This position has direct impact on site compliance. Compliance issues may result if assigned activities are not carried out correctly.

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