Quality Organisation project
A major manufacturer of vaccine and sterile products had just completed a review of the manufacturing strategy that involved the relocation of parts of the manufacturing network to fit in with market needs and to make best use of existing facilities.
A project was developed to restructure the Quality Organisation to meet the needs of the new structure and implement technology and system based efficiency improvements, while maintaining Regulatory Compliance.
The work provided professional technical services and project management.
Our role included:
- Performing Quality Risk Assessments for all workstreams and monitoring of the mitigating activities
-
Overall project management of the various project workstreams with tracking, monitoring and trending of progress
-
Mapping of evidence to support completion of commitments for each workstream (eg, SOP implemented, training delivered, updated job descriptions, etc)
-
Preparing regular progress updates for upper management
-
Auditing schedule to ensure that all projects had completed successfully and maintained corporate quality standards
