Jessica Villavicencio

Project Management Officer (PMO), Budget Management (Capex & Opex), Commissioning & Qualification Procesos & Laboratorio Equipment, Clean media, HVAC, etc. Calibration Management and Wastewater Treatment Plant (WWTP). Governance based in PMI, Eudralex, FDA, ISPE, ANVISA, WHO and others Regulations.

Leading end-to-end Pharmaceutical Projects, Owning the Project Management Office (PMO), Managing Scope, Risk, Cost, and Schedule, Execution Control according planned. Developing & Maintaining GMP-critical documentation: URS, Technical Drawings, Risk Assessments, IQ/OQ/PQ, FAT/SAT, SOPs, Specifications for critical systems such as HVAC, Purified Water, Compressed Air, Nitrogen, Process & QC equipment, and Software Validation.

Commisioning & Qualification: New building for non-sterile oral product, HVAC, Clean media, Black Utilities, Process and Laboratorio Equipment. Software Validación, based in cGMP and GAMP 5. Supplier Management. Equipment Risk Assessment. User Requirement Specifications. Discrepancies Management. Allá governance based in compliance Eudralex, FDA, ISPE, and others strong Regulations/Guidelines.

Quality control activities coordination- Physico-Chemical and Microbiological Analysis of Starting Materias, Bulk and Finish Product, Qualification Management, Analythical Method Validation, Software Validation, Audits, Change Control, Risk Assessment, Deviation, CAPA, Complaints Management. Governance of activities based in Eudralex, FDA, ANVISA, ISO 9001, ISO 13485, ISPE and others.

Quality Management System administracion Internal, External and CMO Auditing. Release of Finish Pharmaceutical Products for Human and Animals, after verify Regulatory and Comercial Compliance, in SAP. Pre-Qualification of a medicine with World Health Organization. Governance based in Global Regulations, WHO, GMP, GDP, GSP, GTP Regulations.