Job description

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 115,000 colleagues serve people in more than 160 countries.

Job Detail : Primary Function / Primary Goals / Objectives: The primary responsibilities of the CAPA Coordinator are multifunctional and include management of the plant GMP/Investigations and Corrective action/Preventative Action (CAPA) program. Primary responsibilities include implementation and maintenance in the following areas: Responsible for the review of investigations and writing complex investigations. Responsible for leading Root Cause Analysis, corrective and preventative action (CAPA). Technical resource for Root Cause Analysis. Training on the investigation/CAPA system.

Major Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system. The CAPA Coordinator is responsible for implementing, maintaining and monitoring the effectiveness of the CAPA Quality System. Assembles CAPA information for monthly and quarterly management review presentations to the plant staff. Reports required metrics to all levels of the organization. Monitors and analyzes plant CAPA metrics and program trend analysis. Ensure all deadlines are met for action items. Reviews non-conformances that impact product quality and provides recommendations and corrective actions and effectiveness plans. Ensures that investigation/CAPA documentation is compliant with GMP, industry standards, Division and Corporate policy/procedure requirements. Ensure investigations are approved by correct areas. Assists manufacturing and other departments in identifying root cause and implementing effective corrective and preventative actions for those circumstances where quality standards are not met. Provides follow-up to batch investigations concerning customer complaints in the RPIC system. Training of personnel on the CAPA system.

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