CARLOS M CASTRO

Inverness, FL *****, 727-***-**** e-Mail – adnyy0@r.postjobfree.com

PROFILE SUMMARY

Accomplished IT professional looking to make a Career change into IT Project Management, IT procurement or iSeries administration. I bring experience working with BPCS/ERPLx, SDLC, SQA, change control, internal/external audits, IT procurement, IT Project management, risk management and business process improvement in an enterprise environment under industry regulations . I offer proven records of maintaining compliance to QMS including FDA 21 CFR part 820/part 11, ISO 13485, cGMP, CAPA and UDI. I strive to provide customer support using: Technology, software development, process improvement, and vendor management relations. I possess strong communication skills, teamwork attitude, and change facilitation nature, resulting in positively influencing others.

EXPERTISE

Management/Leadership

Technical

Functional

Planning/Budget Control

Staff/Team administration

Procurement Mgmt./RFI/RFP/RFQ

Program/Project Management

ERPLx, UDI, RFID, SDLC, EDI, UAT

WMS, Import/Export, Manifesting

Business Process improvement/M&A

Change Control Process/Testing

IT sourcing/Supply Chain

TOP SKILLS

Management/Leadership

Technical

Personal

Program/Project Management

Business Regulatory Compliance

Delegation, Motivation, Influencing

iSeries admin, CL, RPG, Robot, PTF

MS Win Server, AD, DNS, IP, Router

MS Office, MS Project, MS Visio

MES, Documentum, Minitab

Effective Communications

Adaptability and Flexibility

Relationship Management

Customer Support

RECENT ACCOMPLISHMENTS

Dec 2016 – present Frozen Phoenix LLC.

IT Consultant - Medical Device Manufacturing – Windows, GUDID, SOX, eGMP, Project Management.

UDI Compliance, Technology refreshment. Emerging Technology Blockchain, Machine-to-machine (M2M) Communications.

Completed Implementation of UDI compliance Project including Hardware/Software, process changes, software, label updates and validation, unit testing and UAT for a Med Dev manufacturing company.

Providing technical expertise in Blockchain and M2M communication for confidential Global Consulting firm since Dec 2017

Providing expertise in P2P (Procurement to Pay) using Blockchain technology.

Worked as Phone Support for Apple IOS devices

May 2013 – Oct 2015 Valeant Pharmaceuticals (Bausch & Lomb Division) Clearwater, FL

IT Regional Manager - Medical Device Manufacturing – Oracle DB, Windows, iSeries, BPCS, UDI, GUDID, SOX, cGMP

Managed the IT function for 4 US medical devices manufacturing plants in the US, driving accomplishments primarily on Project Management, Process Improvement, Compliance, Risk Management, IT procurement, Technology refreshment.

Managed the SDLC Projects including user requirements, UT, traceability matrix, UAT and training materials.

Delivered Projects to meet compliance to FDA’s UDI regulation for class III devices and Global UDI Database (GUDID).

Executed IT Program Management, Application Software Updates and Controlled Label changes and Validation.

Managed IT procurement including Software Licenses, Hardware maintenance and contract negotiations.

Administered the site ERPLx application.

Feb 2008 – May 2013 Bausch & Lomb Surgical Division Clearwater, FL

IT Site Manager - Medical Device Manufacturing – Oracle DB, Windows, iSeries, BPCS, Virtualization, UDI, GUDID, SOX, cGMP

Managed the IT function the Clearwater medical devices manufacturing plant. Accomplished improvements in Network performance, Server and Application Consolidation, Process Improvement, Technology refreshment and Organization alignment.

Improved Manufacturing process by delivering Project to upgrade Shop Floor Control system and associated infrastructure.

Enhanced Compliance by implementing Enterprise Change Control System Project eliminating obsolete local system and maintaining adherence to QMS including executing SDLC and Label validation protocols.

Managed Vendor agreements, negotiated contract renewals and reviewed contract documentation

Completed internal audits including risk assessment analysis without observations 5 years in a row.

Jan 2004 – Feb 2008 Bausch & Lomb Inc. Rochester, NY

IT Manager – Global Supply Chain – Oracle DB, Windows, AS400, PeopleSoft, BPCS, HighJump, WebShip,RFID, SOX

Successfully completed multiple Global Supply Chain IT projects

Delivered the RFID Compliance Projects to comply with Walmart/Target requests.

Led Projects supporting Global Procurement, and Global Packaging Organizations.

Executed multiple RFx for Software Vendors and Software Licenses acquisitions, updates and upgrades.

Managed the IT departments for Canada and Latin America division (CLAD).

Jul 2001 – Jan 2004 Bausch & Lomb Inc. Rochester, NY

IT Manager – Distribution Systems & Offshore –Optum, Oracle DB, Windows, AS400, BPCS/ERPLx, PeopleSoft, HighJump - RFID

Coordinated all IT Distribution related projects including: WMS, Manifesting, Data Collection, and international Trade Documentation software, PeopleSoft ERP integration with 3rd party Distribution Software, Sarbanes-Oxley compliance and IT sourcing and Change Control Management of those activities.

Assessed the technology portfolio supporting the company’s worldwide Distribution System.

Developed the systems’ strategy for Data Collection, Manifesting, Import/Export Doc and Warehouse Mgmt. Systems.

Completed the IT procurement including Vendor selection and IT project management.

Implemented a US$ 2.4 MM WMS System (OPTUM’s MOVE), which delivered savings of over US$ 700K a year.

Implemented HighJump WMS for 3 Regional Distribution Centers complementing PeopleSoft ERP functionality.

Completed the system integration into Corporate’s ERP, providing cost reductions of CAD$ 300K a year.

EDUCATION

Carabobo University Valencia, Venezuela Industrial Engineering – Systems ND

IUTIRLA Technical Institute Caracas, Venezuela Information Technology (Cum Laude)

George Washington University Washington, DC Master Certification in Project Management

LANGUAGES

Spanish – Native proficiency. English – Full professional fluency. Brazilian Portuguese – Professional proficiency

Contact this candidate