Oversees the plant CAPA Quality System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging.

Responsibilities:

• Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
• Coordinates the exception document process and creates exception documents
• Independently leads complex, high impact investigations
• Ensures all investigations are written according to corporate and site requirements
• Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System
• Ensures all Quality CAPA goals and metrics are met
• Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
• Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant