Certificación Académica Luis Montes De Oca
CVOSOFT tiene el agrado de presentar la Certificación Académica de Luis Montes De Oca.
La misma contiene su perfil profesional y presenta una validación fehaciente sobre sus estudios cursados y las certificaciones alcanzadas en nuestra academia.
Luis Montes De Oca
Miembro desde: Noviembre de 2009 | Legajo de Certificación: FX16Z
Vega Baja / Puerto Rico / Puerto Rico- Profesión: Consultor en Computer System Validation
- Estudios: Universitarios completos
Certificaciones alcanzadas en:
CompartirCertificaciones:
Luis Montes De Oca ha alcanzado las certificaciones que a continuación se detallan.
Certificación Consultor Funcional Módulo MM Nivel Inicial
Número de Matrícula: 4310
Certificación Consultor ABAP Nivel Avanzado
Número de Matrícula: 275
Certificación Consultor ABAP Nivel Inicial
Número de Matrícula: 201
Perfil Personal:
Profesión
Senior CIM Process Support – Engineering Department Jan-09 to Present
Ethicon LLC, San Lorenzo, Puerto Rico (RCM Technologies, Inc.)
· Create and Review computer system validation protocols
· Assessment on manufacturing machines (FAS/MAS) for CAPA issue
· Information System support to the validated computers.
· Computer System Validation lifecycle for Barcode printers.
· Windows Vista migration (Velocity Project) on validated computers (Functional, IQ,OQ and SOP revision)
· Batch Print Data Validation upgrade to Windows Vista
· Label View upgrade to Windows Vista.
SAP Master Data Support – SAP ePES Project Feb-08 to Dec-08
Janssen Ortho LLC, Gurabo, Puerto Rico (ITC&S, Inc.)
· ePES (electronic Process Execution System) Electronic Batch Record SAP interface support
· SAP Master Data Module support
· Engineering Change Management creation
· Manufacturing/Packaging master recipe creation/maintenance
· Creation Bill of Material (BOM)
· Maintenance usability layer of ePES system
· Process step repository maintenance
Senior Computer System Validation – MySAP ERP Project Apr-07 to Dec-07
Cesar Castillo Inc. Guaynabo, Puerto Rico (VALCOA, Inc.)
· Development deliverable documents (Master Validation Plan, User Requirements, Functional Requirements, Installation Qualification, Operational and Performance Qualification).
· Computer System Validation for SAP Sale and Distribution, Material Management and Warehouse Management modules.
· Executes validation and qualification protocols, test scripts and generates final/summary reports.
· Development of Information Technology procedures (Security, Disaster Recovery, Change Control, Good Documentation Practices)
· Information Technology infrastructure audit (COBIT guidance).
· Leads/trains cross-functional teams, with special support to IT, in compliance and validation activities
· Train SAP key users and IT resources for the qualification execution
· Develops and communicates project timeline and status.
Senior Computer System Validation – SAP Project Nov-06 to Feb-07
Bristol Myers Squibb, Manati, Puerto Rico (TARATEC)
· Integration Wireless equipment with SAP.
· Develop and execute protocols for Access Point, Hand Held and Barcode Printers.
· Execution ERP analysis, testing and implementation wireless SAP system.
· Wireless equipment configuration.
· Writes protocols that challenge the critical parameters related to the installation, operation and performance of the related wireless system for SAP implementation.
· Develops and communicates project timeline and status.
· Training and coaching others.
· Development SOP and work instructions.
Senior Computer System Validation – SAP Project Jun-06 to Sep-06
Warner Chilcott Inc, Fajardo, Puerto Rico (TARATEC)
· Technical writer support
· Revision of Fajardo site’s Standard Operating Procedures SOPs for SAP project.
· Develop and approval follow-up SOPs for SAP interface
Senior Computer System Validation – Network Project Jan-06 to May-06
Wyeth Pharmaceutical, Guayama, Puerto Rico (TARATEC)
· Installation and Operational Qualification execution for Network communication Rooms.
· Information system infrastructure support.
· Create and update network drawings (Visio).
· Development and update SOP’s and operational instructions.
· Hardware and software inventory.
Computer System Validation – Industrial Automation Project Jun-05 to Dec-05
Wyeth Pharmaceutical, Carolina, Puerto Rico (TARATEC)
· Validation of Industrial Automation Software and Manufacturing Execution System
· Installation/Operational commissioning and qualification for manufacturing formulation tanks.
· Develop and execute validation documents for Process Control (IQ, OQ, deviations and summary reports).
· Mechanical Installation Qualification and P&ID.
· Process Control System, HMI, CIP, and SIP.
· Operational Qualification of transfer tanks, PCS to control glycol system and water temperature with calibrated thermocouples and Kaye Validators 2000 equipment.
· Development of cleaning validation and media for manufacturing holding tanks.
· Train internal resources for qualification execution
· Develop discrepancy and summary reports.
· Consultant’s supervision.
Computer System Validation – IM Compliance Remediation Project Jan-05 to Jun-05
Cordis, Miami, Florida (TARATEC)
· Remediation of Legacy and new System in order to comply with FDA regulations.
· Generation of System Life Cycle documents such as: GAP assessment, GxP assessments, validation plans, remediation plans, Retirement plans, summary reports, and system specification (DS, FS, CS), Protocols (IQ, OQ, PQ) as per Cordis methodology.
· Computer System Validation assessment and Remediation Plan development for manufacturing and business systems to assure compliance with regulatory requirements (21 CFR Parts 11, 210, 211 and 820), new corporate requirements and industry best practices (GAMP4)
· Generate Requirements Traceability Matrix
Senior System Analyst Jan-98 to Nov-04
Bristol Myers Squibb, Manati, Puerto Rico
As a Senior System Analyst, responsibility included all activities related to the network and data center. Also provide support to computer validation team for data center and network qualification:
· Primary responsibilities are to manage development and production servers, provide PC technical support to end-users on qualified applications within SLAs.
· Responsible for LAN Administration in Windows and Novell platform.
· Proven troubleshooting solution with servers and workstations.
· IS support for business operations through software/hardware implementation and upgrades.
· Maintenance centralized servers, network data and voice communications.
· Document network/system architecture, configuration settings, and procedures
· Design, install, configure and maintain a windows server including Active Directory, DNS, and DHCP
· Maintain and monitor up to date data backups, security measures, and system uptime.
· Coordinate and provide disaster and recovery support to client/server application.
· Desktop and Infrastructure Inventory Management (Asset Inside)
· Support Definity Private Branch Exchange (PBX), Call Accounting, dedicated data, ISDN and phone lines.
· Experience with voice and data connectivity. Knowledge of TCP/IP protocols and Systems Management Server applications
· Experience with Cisco routers, switches, firewalls and VPN technology
· Responsible for designing and developing computer procedures to assure compliance with internal and external audits and regulations.
· Other responsibilities include providing support to Manufacturing applications BPCS/ROPICS systems
· Train users and IT resources in new technologies.
· Supervise temporary and contractor employees.
· Operational experience supporting a 24x7 environment
Operation Specialist Oct-92 to Jan-98
Dupont Merck Pharmaceutical, Manati, Puerto Rico
· Provide End user support to GMP Manufacturing computers
· Responsible for auditing, evaluating, analyzing, documenting, training and release of production batch folder documentation (applying Good Documentation Practice).
· Production scheduling requirements in accordance with quality standards.
· Production Operator responsible for tablet compression and granulation.
· Compliance with CGMP, OSHA and other FDA regulations.
· Knowledge of BPCS, MRP application, Shop Floor Control and Inventory modules.
Estudios
- Bachelor Degree in Information System, Summa Cum Laude, American University of PR - May - 1998
- Associate Degree, Cisco Networking Certification (CNA), Universidad del Este PR. – May- 2004
- Associate Degree in Information Science, American University of PR May - 1997
- Assembly and PC Repair, Advanced Microcomputer Institute, PR May - 1996
Affiliations and Certifications
- Network+ CompTia Certification
- Microsoft Certified Technical Specialist (MCTS-2008)
- A+ CompTia Certification
- NCA Novell Certified Administrator
- Microsoft Certified Professional (MCP)
- American Society of Quality.
Selected Development
- SAP – Benchmark: Materials Management (MM) course.
- ePES Master Data application.
- Security Analyst (Ethical Hacking Training)
- Biotechnology Seminar
- Computer System Validation Methodology
- Commissioning and IQ/OQ protocol execution.
- Programmable Logic Controller (PLC) Seminar.
- HMI SCADA application.
- P&ID reading
- Thermocouples and Glycol tests
Contacto:
Tras completar el siguiente formulario, la información proporcionada en el mismo será enviada de manera inmediata vía correo electrónico a Luis Montes De Oca.
