Edgar Rivera Email & Phone Number

Mexico City, Mexico

México

- IA development and project implementations.- Digital Transformation of Business Process.- Implementation of global and local digital solutions.- Democratization of digital knowledge.- Migration from manual processes to digital processes.- Leadership of multidisciplinary teams focused on digital developments.- Identification of digital innovation solutions.- Process optimization through digital innovation.

México, México

IT site lead for GMS

Guadalajara Y Alrededores, México

• Ensure that flow process for IT global solutions comply the business requirements.• Ensure that testing processes comply with the business guidelines and policies.• Support the administration and maintenance of global documentation.• Training support for global key users.• Risk Management associated with global solutions.• Develop test cases for global solutions.• Communication of business status report (KPIs)• Identification of requirements for global solutions.

Ciudad De México Y Alrededores, México

• Ensure that SAP deployment teams (technical, business, local and global) comply with the internal guidelines, regulatory and quality policies required by each business unit.• Support the implementation of global applications in both dedicated infrastructure and in the cloud.• Approval of global operating procedures, DRP and BCP for global SAP.• Identification of potential risks and approval of risk mitigation plans (Risk Management).• Approval of change controls for SAP - initial / closing phases (Change Management).• Approval of global technical documentation for SAP (User Requirements, Functional Specifications, Design Specifications, Business Processes, Interface Specifications, etc.) using Solution Manager v7.1 and v7.2.• Remote leadership/collaboration and on site with multidisciplinary teams in different regions (North America, Europe and India).• Communication of compliance status reports, potential risks and new project proposals to local and global management committees.• Lead and collaboration with external technical SAP teams (Accenture, Infosys, IBM).• Validation & Compliance lead for global SAP deployments (Mexico, India, Western Europe, Northern Europe, Eastern Europe).• Validation & Compliance lead for update SAP modules like MDM, Solman, BO, BODS, HANA, FI, PP, etc. • Auditor lead for global suppliers related with IT (SAP, ADM Migration Tools, etc.).• Global support in audit processes (FDA, MHRA, ANVISA, INVIMA, COFEPRIS, etc.). • Quality Assurance to approve test executions for SAP using HPQC• Identification of local and regional requirements for SAP configuration. • Development of remediation plans associated with compliance for corporate solutions (Part 11, Security, DRP, BCP, SLA, etc.) related CAPAs and Quality Events.• Leader of global infrastructure qualification projects (network and data center).• Flexibility to work in different time zones (CET, IST, GMT).

Ciudad De México Y Alrededores, México

• Project Manager for Enterprise Solution implementations using PMI methodologies (Manufacturing, Laboratories, Warehouse).• Lead and User Support to increase efficiency of processes through automated solutions.• Project lead for interfaces customized between ERP & WMS. • Coordination of Information Technology area (Project Management, Technical Support, Help Desk, Infrastructure).• Vendor Management for IT Services / Projects.• Lead SDLC for automated solutions in Manufacturing, Warehouse and Laboratory areas (Requirements, Design, Development, Testing and Release).• ITIL & PMI methodologies implemented (Project Management, Risk Management, Change Management, Incident Management, Quality Control).• Process Business Management (Reception, Storage, Sampling, Manufacturing, Disposition, Delivery, Billing). • Lead and creation of Computer Validation area in BMS.• Ensure the compliance of all GxP applications installed in site.• Resources and cost management associated to IT projects.• Responsible to receive GMP and non GMP audits related to computer validation, security, backups, DRP and Contingency Plans. Last audit received: FDA, COFEPRIS, ANVISA, INVIMA, MSAL.• Lean Manufacturing knowledge.

Toluca Y Alrededores, México

• Head of computer validation area.• Update local SOP´s for computer validation purposes with compliance related to local, international and corporate regulations.• Computer Systems Assessment (Automated and Informatics) with GxP implications.• Prioritization of existing Computer Systems.• Validation Master Plan development and maintenance.• WMS validation implemented in an Automated Warehouse (LAKOS – MAPS Interfaces, Reception, Allocation locations for Raw Material, Finished Products in High stowage, Raw Material Sampling, Replenishment process, Pick To Light, Dispatch Orders, Shipment, Invoicing, Stock Reconciliation, and RF in Mobil Stations).• Lead for LIMS implementation (Corporate Solution). Planning, infrastructure, configuration, Implementation, setting, security administration and computer validation.• Validation of Computerized Systems: HVAC Monitoring & Control, Warehouse, Sampling Areas, PW & WFI systems, Vision Systems, Packaging Systems, CIP Systems, Sterilization Systems and Aseptic Filling, Empower Enterprise network, Press Tablet Systems, Data Matrix Verification Systems, Integrity Filter Systems, OCR Systems, ERP interfaces.• Develop SOP (Operational, Administration, Backup, Continuity Plan and Disaster Recovery Plan).• Setting Access profiles in GMP systems.• IT responsible for CAPA and deviation follow up and closing process.• IT responsible to receive GMP audits. • Auditor (internal process audit).• Project development based in Six Sigma.

Master Of Business Administration - Mba

Bachelor'S Degree, Industrial Robotics Engineering