Fergani Anne-Claire

• Quality Council member for WEC and Canada around Distributionand Suppy Chain topic.
• Operational QA support for logistics team (Site transfer, SAP updates, new products integration, qualification of equipment).
• Implementation of the internal audit process on the local distribution center
• performing of the planned internal audit
• Quality issues investigation to identify root causes and raise appropriate corrective action.
• Temperature excursions assessment against stability data and decision making on product disposition (GETM)
• change control, CAPA and audit management in One Track / Exception report management in Soltraqs
• Logistics complaints managament in Bizzmine
• Traning coordinator in Compliance Wire
• Documentation management in One Vault (Document controller, Author, Editor and approver role)

• Module 3 update of MAA file, ensuring accurate data supply and timely approval.
• regulatory expert in project groups, managing batch size increases and analysis method modifications.
• Creation of stability reports and certificates of analysis for successful registration.
• Coordination of implementation of regulatory changes on manufacturing site to ensure compliance.

• Participation in the serialization implementation project as a quality and regulatory expert
• Writing Product Quality Reviews
• Drafting and reviewing specifications
• Updating documentation related to the area of expertise
• Implementation of new processes (monitoring the implementation of regulatory changes on packaging component), implementation of the monitoring of imports and exports of narcotics...)
• Participated in regulatory audits, ensuring company's adherence to industry standards.
• Investigated quality issues to identify root causes and raise appropriate corrective action.

- Review and approbation of manufacturing and packaging production documentation

- quality agreement creation and review

- KPI implementation to follow supplier performance

- Completion and review of Product Quality Review