Quality Professional - Validation

Abbott Ireland (Longford, Ireland) 16 days ago

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 107,000 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 – Longford:
Abbott established a diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents.

In 2004, Abbott’s operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004, and the first product (Architect® TSH) was launched in December of 2005.

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.

Abbott in Longford manufactures 18 diagnostic reagent products for thyroid function, fertility, and pregnancy, cardiology, renal and metabolic. Our products are manufactured to the highest standards of quality and are regulated by bodies such as the U.S. Food and Drug Administration and the International Organization for Standardization (ISO).

PRIMARY FUNCTION:

Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business. 

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.

  • 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.

EDUCATION AND EXPERIENCE REQUIRED:

  • Apprenticeship or relevant third level qualification in Life Science, Engineering, or closely related discipline 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.

Connect with us at [...] on LinkedIn at [...] on Facebook at [...] on Twitter @AbbottNews and @AbbottGlobal.

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JOB FAMILY:

Operations Quality

DIVISION:

ADD Diagnostics

LOCATION:

Ireland > Longford : Lisnamuck

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - Shftpre0 (Ireland)

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

Quality Professional - Validation

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