Rime Rakza

• Management of the department's quality documentation: procedures and batch records: drafting, securing via the existing EDM system, managing publications.

• Management of training for the department: creation of learning paths, learner tracking.

• Monitoring of quality events via performance indicators.

• Coordination of internal and external inspections: implementation of specific inspection readiness tools, responses to auditors, coordination of responses and follow-up of actions.

• Management of sensitive data: securing digital and paper data from creation to archiving.

• Coordination of production workshop activities.

• Coordination of the introduction of new raw materials: drafting specifications, monitoring analyses and documentation until approval.

• Qualification and validation of URS (specifically: climatic chambers and HVAC): drafting protocols, monitoring tests, monitoring non-conformities and deviations, drafting reports.

• Lead of various projects: production workshop revamping, interlock system revamping...

• Coordination of risk analyses for the department.

• Coordination manager for technical shutdown

• Management of quality events: deviation, CAPA, Change control.

• Continuous optimization of various processes using Lean management tools

Project management and Lean Management. Driving the optimization of quality processes using Lean tools. Risk management and compliance of critical processes. Leading cross-functional projects involving multiple departments (R&D, production, quality). Change management and team coordination. Supporting teams in the implementation of new processes and digital tools. Facilitating inter-departmental working groups to ensure adherence to new procedures. Conducting risk analyses and action plans to ensure smooth organizational changes. Quality management and regulatory compliance. Coordination of internal and external audits. Implementation and monitoring of corrective and preventive actions (CAPA). Qualification and validation of equipment, particularly in controlled environments (HVAC, climatic chambers).

Contribution to the optimization of qualification and validation processes for critical utilities (AHU, compressed air, WFI). Updating and harmonizing quality documentation to ensure regulatory compliance.