Eduardo García Cedillo Email & Phone Number

Mexico City, Mexico

México

- Develop and Implement Computerized Systems Validation in order to meet regulations such as FDA, ISO 13485 and NOM-241- Develop Software applications in order to keep Data Integrity based on ALCOA Framework- Manage Calibration program and coordinate local and supplier resources in order to solve planned and on demand work on pieces equipment- Manage Site Validation Master Plan including: Product & Process Validation, Computerized Systems, Critical Supplies and Measurement System… Show more - Develop and Implement Computerized Systems Validation in order to meet regulations such as FDA, ISO 13485 and NOM-241- Develop Software applications in order to keep Data Integrity based on ALCOA Framework- Manage Calibration program and coordinate local and supplier resources in order to solve planned and on demand work on pieces equipment- Manage Site Validation Master Plan including: Product & Process Validation, Computerized Systems, Critical Supplies and Measurement System Qualification- In charge of Management of Change (MoC) System Show less

México

- Manage Quality Engineer Lab resources in order to Support Execution of Process & Software Validation activities and Measuring Methods Validation- Establish stretegies in order to improve Process & Software Validation meeting global and local policies such as FDA, NOM-059, NOM-241 and BD WW Procedures.- Design Measument System Analysis in order to validate measuring methods part of IPC & SPC and In-Line process measuring systems- In charge of transfer, develop, improve and… Show more - Manage Quality Engineer Lab resources in order to Support Execution of Process & Software Validation activities and Measuring Methods Validation- Establish stretegies in order to improve Process & Software Validation meeting global and local policies such as FDA, NOM-059, NOM-241 and BD WW Procedures.- Design Measument System Analysis in order to validate measuring methods part of IPC & SPC and In-Line process measuring systems- In charge of transfer, develop, improve and implement new technology from Headquarter based in France regarding Quality Engineering Show less

México

- Manage Site Software Validation Master Plan as Subject Matter Expert for Computerized Systems and CSD&V Corporate Core Team Member- Training of site validation asociates in Software Validation toolkit based on NOM-059, NOM-241, FDA 21-CFR Prt 11, GAMP 5 and WW Policies as SME- Develop and establish local validation strategies for software validation studies to support engineering , quality and manufacturing áreas- Generate remedation plan for legacy computerized systems

México

- Managing of Calibration program up to 8500 pieces of equipment distributed among 15 Metrology Technicians- Support On Demand activities to Manufacture, Engineering, Quality and Validation Areas.- Schedule HVAC Qualification activities for Cleanrooms- Managing of Budget of Metrology Lab up to $5 MDP (External Calibration, Maintenance and Lab Supplies)- Attend internal and customer audits

México

- Calibrate different measuring equipment such as preasure, temperature, time, pH, conductivity, explosivity, toxicity, force, humidity, high voltage and Go-NoGo gauges.- Execution of HVAC qualification tests for Cleanrooms based on ISO 14644 - Create and Modify SOPs in order to improve and align laboratory activities against to WW criterios- Support to process validation engineers with humidity and temperature dataloggers for Sterilization Chambres profiles- In charge of calibate… Show more - Calibrate different measuring equipment such as preasure, temperature, time, pH, conductivity, explosivity, toxicity, force, humidity, high voltage and Go-NoGo gauges.- Execution of HVAC qualification tests for Cleanrooms based on ISO 14644 - Create and Modify SOPs in order to improve and align laboratory activities against to WW criterios- Support to process validation engineers with humidity and temperature dataloggers for Sterilization Chambres profiles- In charge of calibate all pieces of equipment on PPE (Sterilization plant by EO) Show less