Miguel Eduardo Morán Ortega

• Energy Savings Project GMP Documentation Expert. • Business Development & Strategic Planning. • Project Management. • Project Investments: Steering of new manufacturing equipment. • Maintenance Excellence System global deployment.

• Project focussed on SCADA's type computerized system qualification and validation for monitoring and control of productive and quality control building's critical variables (temperature, humidity and pressure). • Thermal profiles. • HVAC's system qualification. • Incubator's thermal profiles. • HVAC's qualification support. • Water critical system's equipment qualification (TOC).

• Solid & Liquid manufacture process validation. • Design qualification protocols of fabrication and conditioning equipment. • Enhance Project’s critical variables analysis and take of decisions. • Provide input optimization analyses to perform Performance Qualification. • Develop time execution's schedules.

• Physicochemical analyses of raw material, on process and finished product according to MGA’s – FEUM, USP, BP. • Development and emission of reports and certificates of analysis. • Actualization of analysis methodologies. • Raw material standardization. • New products analytical investigation.

• Support in search, implementation and UHPLC validation of analytical methods. • Analysis and report of long term, intermediate and accelerated stability product. • Elaboration and execution of PNO’s of equipment qualification. • Metrology Management. • Review, and follow up of environmental monitoring (total particles). • Knowledge of GLP, GDP, GMP, HVAC system and general lineaments of mexican norms 059, 072, ISO 14644-1, FEUM, USP and BP.