Specialist Quality Assurance

2 days ago

Sligo, Ireland Abbott Laboratories 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 113,000 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 nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, 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.

PURPOSE OF THE JOB

We are looking for a highly motivated individual to join the Supplier Quality Projects team as a QUALITY ASSURANCE SPECIALIST. The successful individual will conduct quality-related activities such as preparing compliant documents & records; review & approval of quality records, product labels and product specification documents, playing a key role in Supplier Quality tasks associated with achieving Third Party Manufacturer (TPM) product compliance to the EU IVD Regulation (IVDR).

MAJOR RESPONSIBILITIES

- Contributes to and ensures timely achievement of overall project goals and tasks. Independently manages daily work schedule to perform assigned tasks.

- Interacts constructively and confidently with colleagues, managers and cross-functional peers in a global environment.

- Ensures accurate and compliant documentation and records and provides compliant solutions to problems as identified. Supports a variety of project work and acts as cross functional team member.

- Review multiple data sources and records at the same time, to identify GAPs and follow leads to investigate solutions. Helps to provide GAP analysis, data sets and justifications in support of change. Uses global and local network to execute changes.

- Ensure that assigned projects and tasks are performed to meet the quality requirements of customers, internal quality systems, internal & external auditors and other external agencies.

- Helps to identify and implement solutions to eliminate quality process inefficiencies, and compliance gaps.

EDUCATION & COMPETENCIES

- 3rd Level Qualification in Life Science, Pharmaceutical Science, Quality or closely related discipline OR relevant combination of education and experience.

- 2 years experience working in Quality, Technical or a related field in commercial cGMP health care facility. Less experience may be considered based on degree level and grades.

- Experience in Design Transfer projects/Design Planning would be highly advantageous.

- Previous experience working with Abbott electronic systems is a plus.

- Experience with Microsoft Word and Excel and having an eye for detail is essential.

- Takes initiative and follows through with others to ensure tasks get completed on time.

- Ability to work independently, with globally based colleagues and with minimal management oversight.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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