Oversees the Business Technology Solutions (BTS) CAPA System by performing and approving root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for IT Systems.
Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements Coordinates the exception document process and creates/approves exception documents Independently leads complex, high impact investigations Ensures all investigations are written according to corporate 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 BTS organizations.
Bachelor’s degree in a technical field, like Biology, Chemistry, Engineering, Computer Science, etc 6 years of experience in the pharmaceutical or medical device industries Demonstrates ability to problem solve and utilize analytical skills Knowledge of Quality/Compliance management, Regulations and Standards