Jensen Jaganathen

Preparation for regulatory inspections and participation as backroomer (EAEU) and scribe (GQA) Preparation and participation in self-inspection ABIS Nord (MSFP) Execution of the Site Quality Performance Review 2022 Creation and management of the department's skills matrix Creation of two e-learning training modules on Inspection (Ilearn - Ispring) - Lean Six Sigma Green Belt certification project Creation of a guide for new employees

Ensure Quality Assurance monitoring and coordination of production activities in accordance with internal documents and quality requirements Guarantee the monitoring and proper application of Quality Systems (Deviations, CAPA, Change Control, Modification Requests, Documentation, etc.) Review and acceptance of production batch records / solutions Guarantee the quality of Thymoglobulin batches manufactured Ensure presence in the clean room (ZAC) through gemba walks and quality tours (compliance with rules - conformity of premises and equipment)

Support production teams in the manufacturing of Thymoglobulin batches in compliance with GMP standards Daily presence in the production area: process observations, equipment inspections, clean room maintenance, 5S, and Data Integrity Management of functional links between the Production department and other departments (deviations, CAPAs, process modifications) Collection of customer needs regarding production and compliance Continuous improvement of production, quality, and safety practices Deployment and monitoring of corrective actions with support services Facilitation of bi-weekly meetings on deviations Creation and facilitation of training to secure and improve production practices