Abbott Laboratories Hiring for Quality Technican Job at Longford , Ireland 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 – 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).

PURPOSE OF THE JOB:

Provides inputs to facilitate quality activities as required. Undertake the role and execute daily activities of Technician Quality with some supervision.

MAJOR RESPONSIBILITIES

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  CAPA: Investigates standard complaints. Identifies and prioritizes medical and reportable complaints. Supports ticket trending process and maintains Quality Records. Maintains awareness of industry regulatory standards.

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  Communications: Communicate and collaborate effectively within team.

• Documentation: Maintain relevant documents and records.

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  Generic Basic Requirements: Provides input into the annual departmental budget.
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  Manage Product and Process Improvements: Participate in Project and Process improvement activities. Monitor performance of manufacturing processes and implement required improvement activities. Suggests to manager and implements process improvements within own work area that fosters a culture of continuous improvement. Supports work area processes and product development/improvement projects. Provide Quality support to key processes and product development/improvement projects.
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  Management of Computer Systems: Maintain and update relevant computer applications.
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  Other duties: Perform all duties as assigned.
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  Quality /Compliance: Support manufacturing and testing operations as required, adhering to Good Manufacturing Practices and Good Laboratory Practices. Possess a basic understanding of the Quality System, including the Subsystems and is familiar with the Quality System Key processes. Keep abreast of the standards that regulate our industry. Participate and take all trainings and reviews as required on the Electronic Training Management System -ETMS. Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well at the Abbott Global and Technical standards. Comply with Abbott Quality System (QS) requirements.
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  Share Quality knowledge: Share quality knowledge, liaising with colleagues within team.
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  Training: Undertake all trainings and reviews as required on the Electronic Training Management System -ETMS.
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  Testing Specific: Complete Quality testing as appropriate for products per procedures and review all data to determine conformance with specifications.Ensure that plant Environmental Monitoring program if applicable is executed per procedural requirements and schedule, and that environmental data is tracked and trended . Provide information for tracking and trending of data as required. Take appropriate action per procedural requirements and schedule when test results specifications are not met.
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  IQA Specific: Conduct Inspections of incoming items per procedural requirements and schedule. Ensure storage of samples and documents in the appropriate filling systems.
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  MQA Specific: Review batch record documentation to ensure manufacturing has been completed per procedural requirements.

EDUCATION

• Ideally a bachelor’s degree in a science or closely related discipline or relevant equivalent experience. At a minimum Leaving Certificate educated or equivalent.

• andidates with Leaving Cert accreditation only will require a minimum of 2yrs manufacturing experience within a regulated environment
• Candidates with a relation BSc previous experience in a regulated manufacturing environment would be an advantage

KEY SKILLS

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  Problem Solving: Identify and escalate any potential non conformances / issues to team Leader.
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  Task Assignment/ Ownership: Perform activities as assigned by Team leader / Manager. Apply appropriate actions to resolve with support from Team Leader. Support relevant activities.