Alèxa Farnabe

Coordination of the quality management system according to ISO 17025 standard and in compliance with Cofrac requirements. Preparation, execution, and follow-up of internal and external audits. Development of corrective action plans and monitoring of their effectiveness. Implementation and improvement of steering tools (dashboards, compliance matrices, action plan tracking). Monitoring of quality indicators and analysis of their evolution for early detection of deviations. Management of document control: validation, distribution, archiving of quality procedures and records. Active participation in management meetings and communication of quality results. Leading internal awareness sessions on quality best practices and regulatory requirements. Management of internal discrepancies, handling of non-conformities, and implementation of corrective actions.

Responsible for the implementation of the complete quality system for the SIMA PHARMA division, according to ISO 13485, ISO 9001, and Good Manufacturing Practices (GMP) for medical devices. Creation of all initial quality documentation: quality manual, process mapping, activity sheets, procedures, records, and supporting documents necessary for the proper functioning of the system. Monitoring of quality indicators and regular updating of dashboards. Participation in internal and external audits (ISO 9001, ISO 13485, GMP). Drafting of management support documents for process reviews. Monitoring of non-conformities and customer complaints. Management of supplier evaluations and associated actions.

Performance of physicochemical analyses on pharmaceuticals (finished product, semi-finished product, excipient, active ingredient, and release quality control). Application of GMP/BPF, GLP, ISO9001 standards. Processing of results and verification of batch conformity before market release. Management of deviations and investigation of OOS results. Monitoring and maintenance of analytical equipment (equipment referent).