CAPA Specialist

LOCATION: Ireland > Longford
TRAVEL: Yes, 10 % of the Time

We currently have an open position for an CAPA Specialist and this role involves the following:

Primary Function

• Support the site non-conformance process through developing and maintaining expertise the GQMS (Global Quality Management System) 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 & Experience

• You will have 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.

With

• A minimum of 20 months experience in a regulated environment of which 12 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.

Key Skills

• 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.

For more information and if you wish to apply, contact Alan O Riordan on alan.oriordan@lifescience.ie.