• Coordinate meetings as risk facilitator to generate synergy to identify, mitigate, and establish action for the correct management of the risks in the different systems, process• Collaborate in the generation of documentation regarding the control of the risks • Asses the risks for system, process, or product that may have GxP influence• Implement the difference Risk Management Tool like FMEA, comparison matrix, risk estimation matrix, Hazard analysis, in the cases in which any of these tools are required• Management of the events, CAPAS, action plans through the PHENIX tool, regarding the correct management of the risks for process with GxP impact• Support the Sanofi Global Requirements regarding risks or new requirements generated by the Global Health Authorities like MHRA, Health Canada, among others• Develop the Investigation Reports (IR) regarding alerts generated for suppliers, manufacturers of APIs or raw materials for Sanofi and sanofi third parties, taking into account the Risks Escalation Process.

Coordinate all the necessaries activities to carry out the process and computerized validation of the company. Validation of the HPLC, gas chromatography systems, UVs, CAPA software etc. Execution of the validation of control dosification software at the production plan, serialization level, support production validation documentation and activities of validation to clients like GlaxoSmithKline, Bayer, Pfizer, consilient health, perrigo among others.

Being member of the quality assurances team I was in charge of looking out for the quality of the products that were manufactured at the production plants of Procaps S.A, take out of quarantine the materials that were needed for production, taking samples for the microbiology department of the company, and uploading these using the SAP software for this and many others functions through out the transactions of this software.

Developed quality documentation for the Bioanalytical laboratory of the Universidad del Atlántico, taking part in the activities carried out to validate the quantification of molecules in human plasma. Also write technical documentation for the use of the specialized equipment of the laboratory.