Agathe Ebongo

Personnel monitoring (updating personnel files: CV, job description…), management of employee arrivals and departures

- Personnel training: establish the annual training plan, monitor the onboarding process for new employees, develop training PowerPoint presentations and deliver training, Manage related files,

- Mastery of outsourced activities: develop the annual audit plan (updating subcontractors (cmc, production, marketing, pharmacovigilance, clinical operations…), risk analysis…), subcontractor monitoring (monitoring meetings, audit follow-up)

- Documentation: Documentary system reform project, update and draft SOPs (CAPA management, audit, GDPR…), SOP dissemination

- Deviation management (closing backlogs,)

- Follow-up of internal CAPAs and those resulting from subcontractor audits

- Change control management

- Lead weekly quality meetings (slide development, activity monitoring…)

- Prepare the annual quality review

- Inspection readiness project

Draft quality agreements (QTA) between the various Sanofi entities and identified and qualified subcontractors (depositories, transporters, and freight forwarders)

- Draft test protocols and other quality instructions (Quality Position Paper…)

- Monitor activities; Participate in and lead steering meetings

- Monitor recipient validation

Draft and optimize qualification processes for suppliers and subcontractors (depositories and transporters): review specifications, draft procedures.

- Quality monitoring of subcontractors: monthly quality committee, participation in the annual evaluation questionnaire review…)

- Deviation management

- Recipient qualification

- Quality complaints: registration and follow-up

- Plan, prepare, and participate in self-inspections and internal audits: Product destruction, QMS (deviation management system, complaints, recalls/batch withdrawals, self-inspection system, …)

- Draft and update Product Quality Logistics Sheets

- Prepare and participate in quality meetings