Quality Specialist - CAPA

Job description

JOB DESCRIPTION: MAIN PURPOSE OF JOB - This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out in the Abbott Dundee Employee Handbook. - Working as part of the Product Support Team, the Coordinator, CAPA is primarily responsible for providing ownership, oversight and reporting of Nonconformance and Corrective and Preventive Action (CAPA) processes at Abbott Dundee. ACCOUNTABILITIES: - Ownership of the Nonconformance and Corrective and Preventive Action (CAPA) System. - Assist in the initiation, processing and completion of QI/CAPA records in the electronic system. - ensuring record owners are assigned, and timely responses and approvals are provided in alignment with quality goals. - Assessing and documenting the impact of each Nonconformance event to determine the requirement and extent of investigation. - Lead meetings and communications for QI/CAPA updates, information, and concerns, including chairing site CAPA Review board. Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues. - Responsible for collation of metrics and reporting on...