CAPA Specialist

at  Abbott Laboratories

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 o6,000 people across ten 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.

EDUCATION & COMPETENCIES:

You will have a Diploma/Degree level education – science/engineering qualification with at a minimum of three years manufacturing experience in a quality assurance function within a regulated environment.
Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews

PURPOSE OF THE JOB:

• Responsible for reviewing all Quality Records (QRs). Will provide leadership and direction for QR initiation and root cause analysis.
• Responsible for ensuring that site Quality CAPA Metrics are recorded and reported as needed.

MAJOR RESPONSIBILITIES

• Conduct weekly or more frequent CAPA meetings to track timelines and quality of Quality Records (QRs) and associated actions.
• Provide Leadership and support on the Corrective and Preventative Action System to all plant personnel.
• Ensure that all appropriate site Quality CAPA metrics are recorded and verified. Report on monthly metrics with regard to CAPA and QRs.
• Provide training to site subject matter experts and plant with regard to CAPA requirements as guided by division/corporate where required.
• Review site QRs to ensure compliance to Rubric requirements and associated site and division policy requirements.
• Collate CAPA information for site management review and area tier 3 information.
• Provide guidance in management of unexpected manufacturing events, required bracketing and containment and associated sampling if required.
• Complete Global CAPA review for impact to Cootehill site and support elevation process for site issues as required post QR approval.
• Support the QA CAPA IT System (ABTRAQ) through which investigations and CAPA’s are documented. This also involves the development and support of plant SME’s and general users.
• Liaise with other plant CAPA Specialists in Community of Practice meetings to address global concerns on CAPA opportunities/systems.
• Food Safety Team member – actively participating in Food Safety Team meetings, as required.
• Participate in internal audits and compliance walkdowns.