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 nutritionals products. In Ireland, Abbott employs over 5,000 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.

We are looking for an Operations Technical Specialist to join our manufacturing team and this role will involve the following:

Primary Function

• Support the site non-conformance process through developing and maintaining expertise the Trackwise process and by facilitating the timely generation and completion of non-conformance and potential non-conformance reports.

• To ensure the plant meets its customer quality, service, regulatory, financial and safety goals through effective technical support of Diagnostic products.

• To provide the necessary support to the site non-conformance process in the centralised CAPA group, ensuring that timeliness targets at site and divisional level are met for all open CAPA items, and to ensure a high standard of technical writing is employed in the building of non-conformance / potential non-conformance reports.

• To facilitate cross functional meetings associated with non-conformances / potential non-conformances and to populate the GQMS system with inputs provided by area owners.

Major Responsibilities

• Develop Subject Matter Expertise, and take lead, in designated CAPA/process/technical speciality.

• Train / mentor fellow team members, including peers, as required.

• Establish oneself as key contact for designated process.

• Develop and maintain working relationship with cross-functional peers, including Technical Support, Quality and Supply Chain.

• Provide necessary support to production schedule requirements as designated by Team Leader.

• Champion the principles and practices of GMP/GLP and 5 Pillars. Lead by example, and provide mentoring support for team members.

• Minimise generation of deviations by ensuring that all relevant documentation is being followed.

• Demonstrate an understanding of the application of the Quality Policy through daily activities.

• Ensure effective communication of process information and manufacturing issues to Team Leader.

• To ensure that the plant meets the quality requirements of its customers, internal quality systems, internal & external auditors and other external agencies.

• To liaise with, seek appropriate advice from and report when necessary to colleagues in Sligo, Lake County, Dartford and Wiesbaden.

• To participate in the AIDD LONGFORD Self-Assessment procedure per site procedures.

• To assist in the periodic review of controlled documents per site procedures.

• Maintain ETMS To Do List.

• Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Abbott Global & Technical Standards.

Supervisory / Management Responsibility

• Works independently or Individual Contributor.

Education

• The following level of education provides a necessary foundation for this Job function:

• A third level qualification in a relevant Chemistry or Life Science discipline

Or

• Relevant professional qualification as this level of education provides a necessary foundation for this Job function.

Background

The following experience provides a necessary foundation for this Job function:

• A minimum of 24 months experience in a regulated environment of which 18 months is in the manufacturing/testing or support of diagnostic products.

Or

• A relevant post-graduate qualification with 12 months experience in the manufacturing/testing or support of diagnostic products.

Or

• A relevant professional qualification, together with a minimum of 12 months experience of supporting the manufacture/test of diagnostic products.

• Excellent communication and presentation skills.

• Advanced organisational skills and attention to detail.

• The ability to work co-operatively and effectively with others to establish and maintain good working relationships.

• A proven self-starter with the highest level of integrity in the successful completion of your work.

• Excellent time keeping, attendance and performance record are a pre-requisite for this role.

Accountability

The Operations Technical Specialist will be part of the Centralised CAPA team and will be responsible for ensuring that all applicable CAPA procedures performed as part of the role are adhered to and Trackwise timeliness issues are resolved. Failure to do so could result in customer complaints, ultimately product recalls and significant financial losses.

• Individual is given authority to carry out duties without close supervision.

• Regular team meetings and one-on-one meetings with the Team Leader.

• Periodic goal reviews, annual performance and career development reviews.