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 Diagnostics 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.
We are currently seeking a Quality Professional - Validation Engineer for a 12 month contract.
Objective
To ensure that the Quality System of the Abbott Diagnostics Sligo follow Division and site Quality System requirements and recognised international standards.
Primary function
Conduct quality-related activities to deliver consistent, high-quality documents, services, products and processes, which adds value to the business.
Responsibilities Include:
Ensure all aspects of activity within the Quality Engineering Group adhere to required policies and procedures, including safety and training.
Ensure that the plant meets the quality requirements of its customers with respect to Validation and Calibration,ISO 9001:2015 / ISO 13485:2016, In Vitro Diagnostics Directive, Division & Corporate Policies and other external standards.
Be involved in all Validation Cross Functional Teams (CFT’s) at the site to ensure adherence to required policies and procedures, including safety and training.
Assist in preparation and execution of validation protocols.
Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues.
Lead validation aspects of Facility, Utility, Equipment qualifications
Conduct Test Method Validation, Gauge R&R
Lead software validation and 21CFR Part 11 assessments
Assist in the development of the existing Validation Program at AIDD to ensure continued compliance to the necessary regulations.
Collate and Report on relevant Validation data/matrices.
Ensure prompt attention to the Quality Engineering Team/Unit Leader, Quality Engineering Manager and Quality Manager on areas of non-compliance.
Ensure all Validation and Calibration documentation meets the requirements of Quality Records Procedures.
Develop and rollout ‘Validation Training’ for the site on subjects assigned by the Quality Engineering Team/Unit Leader / Quality Engineering Manager.
Keep abreast of developments in customer requirements to ensure the plant continues to produce quality products under regulatory requirements.
Liaise with and seek appropriate advice from other Abbott plants worldwide.
Participate as required in project activities to achieve plant goals.
Ensure all relevant employees are aware of Division and relevant International Standards and their implementation throughout the plant.
Participate in identifying and implementing cost reductions, which do not adversely impact product quality.
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 minimisation are adhered to and improvements made where possible.
Education and Experience Required:
At least 3 years of work experience in Quality or related field experience; Less experience may be appropriate with an advanced degree.
Validation experience is preferred
Excellent communication, team and organizational skills required.
Ability to use own initiative and be proactive in the management of assigned tasks to set and meet deadlines.
Ability to work cooperatively and effectively with others to establish and maintain good working relationships.
