Project
- Management of the quality manual and the Master File site
- Management of quality documents (drafting, review and archiving): policy, processes, procedures, templates and instructions based on the activity carried out
- Staff training on documents
- Training for internal, external and inspection audits
- Management of non-compliance/anomalies/incidents/deviations, CAPA and complaints
- Management reviews/product quality/quality approval
- Change and risk management
Challenges
- Quality : 4/5
- Cost : 2/5
- Deadlines : 3/5
- Security : 5/5
Delivery
- Definition of user needs
- Preliminary design (studies, planning)
- Writing and updating of documents
- Exchange control, claims and CAPA management
- Product control
- Process/product risk analysis
- Support in implementing and monitoring indicators
- Regulatory watch
Summary
Project duration
12
months
