SUMMARY:

• Quality Assurance Guidance
• Calibration Program Methodology & Compliance
• Risk Management Methodologies (Risk Assessment, Risk & Mitigation Controls)
• Data Migration Methodologies
• Six Sigma & Project Management Methodologies
• Business Intelligence Methodology (Informatica, Business Objects)
• Business Systems Applications (SAP (ECC 5, 6, 7)), Catalyst WMS, Trackwise, Regulus, Delta V, BPCS)
• LIMS - Darwin, Biovia
• Wireless Methodologies - LAN & RF Devices configuration & validation
• Change & Document Management Systems - Collaborative Material Management (cMat), Trackwise, Documentum, Regulus,, Blue Mountain, Agile
• Testing Strategies development & deployment Tools - HP Quality Center
• Supply Chain Lifecycle (Planning, Procurement, OSCEE, Inventory & Warehouse Management, Manufacturing Operations, Sales and Distribution)
• Validation Methodologies (Computer Systems Validation (CSV) & Systems Development Lifecycle (SDLC)) - Validation Deliverables, Deployment, Audits & Periodic Reviews
• Health & Safety Methodologies (Safety inspections & Audits, Ergonomic Evaluations, SAP EHS)
• Regulations and Standards: FDA 21 CRF Parts 11, 210, 820
• ISO 13485:2003, ISO/IEC 17025:2005, GMP, GAMP, SDLC
• SAP Subject Matter Expert (IM, WM, QM, PP, SD, APO)
• Virtualization Tools - VMWare
• Facilities Qualification (Warehouses, Purified Water System)
• Equipment Validation (Laboratory, Manufacturing)
• Temperature & RH Mapping exercises for facilities & equipment qualification

WORK HISTORY:

Site Location Lead

Confidential, Puerto Rico

Responsibilities:

• Project Management Lead for timelines for the project / release structure and method of delivery (Agile methodology)
• Understanding of LIMS / BIOVIA platform and domain understanding of client laboratory methodologies and process flows
• Configuration and connection of Ethernet Wired/Wi-Fi devices for Laboratory instruments connection to BIOVIA ELN system
• Administration activities for BIOVIA CISPro Inventory Management System
• In person interaction with Confidential business owners, IS team to understand specific requirements and Validation documents design
• Lead and coordination of Legacy Systems Data migration strategy and activities implementation
• Perform recipe maintenance in BIOVIA Compose/Capture module
• Maintain and provide project metrics/reports to stakeholders
• SharePoint & Collaboration Sites
• TIPCO - Spot Fire
• On site / off shore model of operation.

Validation Engineer Consultant

Confidential, Massachusetts/San Juan, Puerto Rico

Responsibilities:

• Execute a defined validation strategy against the policies and procedures governed by Philips Healthcare Software Development Lifecycle Management methodology (SDLM) site.
• Guidance for validation deliverables development and maintenance as defined by the SDLM procedures.
• Participate in the functional risk assessment gathering information from corresponding SME’s and provide QA and compliance feedback to Business and Information Technology areas on actions items as required.
• I dentify potential gaps from a regulatory perspective from content provided and complete all activities which ensure finalization and approval of validation records demonstrating compliance with SDLM requirements.
• Support Validation documents development as required: Impact/Risk/Part 11 Assessments, Validation Scalability Evaluation, Validation Plan, User Requirements Specifications, Functional Requirements Specifications, Design Specifications, Test Plan, Installation/Operational/Performance Qualification, Test/Validation Summary report/Supplier Qualification
• Document maintenance using Agile Document Management System
• Projects status report/metrics maintenance using Share Point technology

SAP Validation Consultant/CSV Consultant

Confidential, Brooklyn Park, Minnesota

Responsibilities:

• Manage the validation of the SAP Enterprise Resource Planning (ERP) system for the Brooklyn Park, Minnesota (BP) site.
• Act as the Brooklyn Park, Minnesota (BP) site liaison for the validation effort and as an extended arm of both the validation manager and the project manager to help the users feel comfortable with the project and keep project on track. Work with system analysts in design reviews. Confirm that the configuration details are updated in configuration management tool and user requirements are met.
• Participate in the functional risk assessment and perform necessary follow up with users on actions items.
• Other responsibilities:
• SQL Platforms Validation documents revision and update.
• Former Baxalta SOPs conversion to Taxeda
• Environmental Controlled Systems (ECS) Temperature & Humidity Mapping Study Guidelines design
• Temperature & Humidity Mapping Study execution for ECS

Validation & Qualification Consultant

Confidential

Responsibilities:

• Warehouses Facilities Temperature Feasibility Study
• Warehouses temperature and RH control assessment to ensure compliance with materials storage requirements as per MSDS
• Feasibility study to identify current temperature and RH control conditions
• Materials Storage Conditions evaluation to establish criteria for temperature and RH mapping range acceptance criteria
• Temperature and RH Data Loggers configuration for Temperature mapping recording requirements
• Temperature and EH Mapping exercise to ensure compliance with material storage requirements and to register and collect temperature supporting data
• Mapping results data analysis and organization to generate and provide results metrics
• Feasibility report to document and summaries study results
• Warehouses Facilities Qualification activities
• Construction/Installation/Operational/Performance Qualification document design
• Facilities Temperature and RH Mapping as part of equipment qualification
• Installation/Operational/Performance Qualification execution as part of site three (3) Warehouses validation activities

Validation Consultant

Confidential

Responsibilities:

• Installation/Operational Qualification (IOQ)
• Performance Qualification
• Laboratory equipment validation documents design
• Fisher Scientific ISOTEMP Freezer Temperature Mapping
• MVE Cryogenic Freezer Installation & Operational Qualification
• Laboratory equipment Temperature Mapping as part of equipment qualification
• Fisher Scientific ISOTEMP Freezer
• MVE 205 LN 2 Cryogenic Freezer
• Calibration instruments (standards) evaluation
• Status/progress reports and metrics

Compliance Consultant

Confidential, Puerto Rico

Responsibilities:

• Calibration Preventive Maintenance and Equipment Calibration program assessment as part of mitigation plan for response of observations report by regulatory agency
• Evaluation of Calibration procedures to identify improvement opportunities and meet regulatory agency observations response
• Evaluation of Optical equipment calibration records (560 out of 5,000 plus instruments and calibration standards) to identify calibration process/documentation issues and improvement opportunities
• Equipment Calibration Program Assessment report design for stakeholders
• Mitigation Plan design based on assessment results
• Mitigation Plan execution support
• Risk Management activities execution for new manufacturing lines implementation
• Validation deliverables documents for manufacturing operations (SCADA, Netstal, Hekuma)
• End Users & personnel training as required
• Project Budget against expenses reconciliation. Metrics maintenance

SAP Consultant

Confidential, Puerto Rico

Responsibilities:

• SAP Validation remediation solution assessment for SAP Latin America (LATAM) sites
• Change management compliance GAP analysis
• 7,000 plus SAP changes analysis to identify GxP classification and change compliance issues
• Risk assessment to identify & establish compliance remediation strategy
• Validation Plan & deliverables
• URS/FS
• Testing & Defect Plan (OQ, Regression, PQ)
• Risk/Fault analysis for remediation action plan recommendation
• TM, VR
• End users trainings

Senior Technical Consultant

Confidential

Responsibilities:

• Responsibilities:
• Laboratory Validation documentation design and/or review to maintain compliance
• Laboratory equipment Validation activities execution

CSV Consultant

Confidential

Responsibilities:

• Compressed Air Room and H&K equipment commissioning and qualification

SAP Consultant

Confidential

Responsibilities:

• Responsible for SAP Master Data maintenance as part of SAP ECC 6.0 release implementation. Data governance maintenance in ECC SAP PM and/or Collaborative Material Management Tool (cMat).
• Responsible for all related validation documentation and testing strategy development & execution activities.
• Support business operations management to maximize management effectiveness while meeting project implementation timeline and milestones.
• End users training as required

Validation Consultant

Confidential

Responsibilities:

• Responsible for validation & commissioning activities for USP Purified Water system.
• Validation Plan
• IQ/OQ documents design & execution
• Field Commissioning activities execution

VM Ware Validation Consultant

Confidential

Responsibilities:

• Responsible for validation activities for VMware Virtualization Tool implementation.
• VMware configuration to meet client requirements
• Validation documents design
• Testing strategy development and activities execution
• End users training as required

Vendor Audit Consultant

Confidential

Responsibilities:

• Responsible for support Confidential for Vendor Audit response activities from clients ( Confidential )
• Confidential Vendor Audit Questionnaire evaluation for response recommendations
• Confidential operational procedures evaluation to identify improvement opportunities (Software version control, Document Management, Security, DRP)

Confidential

Sr. Business Analyst

Responsibilities:

• Integration with Global Teams for specific Site GLOBAL CORE design requirements implementation
• Implémentation Validation activities - Change Management (Trackwise), Validation Plan
• Collaboration with validation deliverables documents; design and execution: Validation Plan, Requirements, Roles & Responsibilities, Design & Configuration Specs, Test Plan & scripts, Protocols, SOP plan, Impact-assessment, Specific Site specifications, CSQ audit, Deployment, Training Plan, BCP
• Documentation maintenance using Regulus Document Management System
• Testing strategy development and activities execution using Mercury Quality Center System
• Post-implementation issues solution - Stabilization meetings
• Project progress metrics
• Site manufacturing operations/Supply Chain IT Liaison for consultation & support
• Primary IT resource for projects related vendor negotiation and hardware/software purchases
• Local representative for Global SAP Center of Excellence (COE) support organization
• Application updates & procedures End Users training as applicable

Business Intelligence Project implementation Lead

Confidential

Responsibilities:

• Project activities - Microsoft Project (Project progress meetings, accountable for project schedule datelines monitor/meeting)
• Implementation Validation activities - Change Control, Validation Plan, deliverables, related SOP’s
• Analysis, integration and reconciliation of Business applications data into a common replication database for reports design (Informatica, Business Objects)
• Reports Validation activities - Change Control, Requirements, Specific Site specifications, Testing, CSQ audit, Deployment, BCP
• Testing strategy development and deployment
• Development of computer software validation strategies CFR 21, part 11
• Site processes & data evaluation for process/labor improvement needs
• Site business areas meetings for improvement opportunities identification
• Primary It resource for vendor negotiation and hardware purchases
• Business reports customization to meet site specific requirements for metrics/process-labor improvement (Business Objects) – 1 Million dollar plus site savings since project implantation on 2008 – Global MI&CS Productivity Award
• Reporting tool usage End Users training as required