Purpose:

Performs 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
• Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
• Ensures all investigations are written according to corporate and site requirements
• Participates in implementation and maintenance of the Quality System to meet all applicable regulatory requirements
• Effectively collaborates/partners with other Quality areas and departments within the plant