Quality Training Compliance Specialist IVDR

JOB DESCRIPTION:

Quality Training Compliance Specialist (FTC)

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 114,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Abbott Galway

Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, which delivers annually more than 2 billion tests. As the global leader in point-of-care diagnostics, Abbott offers the broadest portfolio of best-in-class rapid tests, services, and handheld devices across all healthcare settings: the lab, the clinic, remote healthcare outposts, retail outlets, the patient's bedside and at home. Our industry-leading near patient tests and services are unmatched across key health and therapeutic areas, including: infectious disease, cardiometabolic & informatics, toxicology and consumer diagnostics.

One of the key functions in Galway is Global Business Services, which provides number of shared services activities across finance, purchasing, quality, technical and customer services for Europe, Middle East and Africa (EMEA). Various global and EMEA commercial and operational management teams across our infectious disease and cardiometabolic businesses are also based in Galway, overseeing the supply of millions of rapid tests from HIV to diabetes to COVID-19, to patients in many regions across the world.

Position Summary

The position of Quality Training Compliance Specialist is within our Infectious Disease business unit (BU) supporting sites globally.  This role provides training support and expertise to employees to ensure continued compliance with Quality System and administration of the BU Learning Management System. The Quality Training Compliance Specialist is responsible for the maintenance of the Learning Management System, training reporting, and records. Please note this position is a Fixed-Term Contract.

Main Responsibilities

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Provides Subject Matter Expertise on the learning process including learning management system to other functional areas.
• Ensures effective communication, monitoring and promotion of learning activities.
• Liaises with Division, Managers and Team Leaders to continuously improve learning processes and/or systems.
• Establishes and maintains a direct and proactive relationship with internal and external customers, has a strong understanding of current customer needs, anticipates and addresses issues, escalating as applicable.
• Authors and reviews learning documentation/material.
• Supports audit readiness to ensure successful audit inspection results related to the Learning system and/or processes.
• Ensures training program meets quality standards.
• Coordinate and support completion of training programs that are required to meet cGMP requirements.
• Maintains applicable administrative procedures and policies to ensure compliance with business process and regulatory expectations.
• Conduct training curriculum reviews and revise training plans accordingly
• Create and assist with the development of training materials.
• Coordinating resources (other presenters/instructors, course materials, training space, etc.),
• Perform other duties and projects as assigned

Education/Experience/Skills

• BS in preferably in Education, Science, Engineering, or a related discipline, or equivalent combination of education and experience.
• Experience in Quality Management Systems preferred.
• Experience utilizing word processing software (e.g. Microsoft Office - Word, Excel and PowerPoint)

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

DIVISION:

ID Infectious Disease

LOCATION:

Ireland > Galway : Parkmore East Business Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable