Aquino Almeida
973-***-**** ( abmq5u@r.postjobfree.com
SUMMARY: Masters in Information Systems from Stevens Institute of
Technology. Resourceful and highly skilled professional with diverse
experience in the Healthcare and Information Systems. Major strengths
include business knowledge, problem analysis and solving, effective
communication, ability to work well with diverse groups of people,
planning/organization efficiency.
. 8 years information systems experience in structured software development
and implementations using Software Development Life Cycle methodology.
. 8 years experience in testing / validation of computer system
applications, understanding of FDA regulations
. 8 years experience in software configuration and support in
regulated environment.
EXPERIENCE: Merck
01/ 10 - Present
Project Lead (Consulting Assignment)
Manage and lead the implementation effort on TrackWise Global Customer
Complaints. Responsibilities include:
. Conduct prototype and design review sessions with business
representatives.
. Work with the QA/ Validation teams to successfully validate implemented
systems.
Bristol Myers Squibb Co.
07/ 05 - 01/10
Project Implementation Lead (Consulting Assignment)
Managed and led the development effort on over ten Trackwise
Implementations across Global Business Units within the "TrackWise Center
of Excellence (COE)" at Bristol Myers Squibb Co. Projects included
tracking EMEA BCF & Compliance, CAPAs, Product Recalls, Government
Inspections/Interactions, SRC/SAP/NDC Material Tracking System, Global
Quality and Regulatory Compliance Audit Tracking (GQRC) - GLP & GCP, 3rd
Party Mfg. Tracking, Waste Vendor Tracking & Actions Tracking.
Responsibilities include:
. Responsible for project cost estimation, project resource tracking and
project timelines.
. Oversaw teams and developed/configured projects from end to end in
validated and non validated environments.
. Facilitated business teams in establishing global business processes and
in defining system requirements.
. Conducted prototype and design review sessions with various business
client representatives to help with business process evaluation.
. Coordinated with the QA/ Validation teams to successfully validate
implemented systems.
. Ensured that all work is conducted in accordance with corporate
standards, SOPs and guidelines pertaining to Computer Systems Validation,
Good Documentation Practices.
. Responsible for project cost estimation, project resource tracking and
project timelines for Global Projects in excess of $500,000.
Cardinal Health, Piscataway, NJ
10/04 - 07/05
Global Lead
Led the development & implementation of Global Quality Tracking System
(GQT) in TrackWise 6.0 for 15 workflows across 25 global sites. This was
a 21 CFR Part 11 compliant system for Cardinal Health's Supply Chain
business geared towards delivering regulatory solutions to critical
business functions, such as, Regulatory, Sterile & Oral Technologies,
Packaging Services and Pharmaceutical Distribution. Responsibilities
included:
. Facilitated design review sessions as required, and ensured that
Corporate SOPs and methodologies are strictly adhered to.
. Developed System Design Specification documents and Installation
Qualification protocols for each application. Reviewed Validation Plans,
Summary Reports, Traceability Matrix OQs / PQs.
. Prepared General System Use, Local System Administration and Global
Administration SOPs for GQT.
Schering-Plough Research Institute, Kenilworth, NJ
05/03 - 10/04
Sr. Systems Analyst
. Provided regulatory compliance support services to the business and IT
groups to validate and implement Documentum's GxPharma, a cGMP, cGLP,
cGCP, and 21 CFR Part 11 compliant system. GxPharma was designed to
manage the control of documents using document lifecycle and workflow
automation and will provide SPRI with a secure document management
environment to manage and control SOPs, lab procedures, guidelines and
other related documents throughout their lifecycle. Responsibilities
included:
> Worked with vendor to develop validation documentation including User
and Functional Requirements Specification, Testing Plans, scripts,
summary reports.
> Assisted in developing Installation/Operational Qualification
Documents for each validated environment.
> Managed and coordinated the System and Integration testing and
assisted in Performance Qualification/User Acceptance Testing.
. Part-time Project management for the report validation initiative for
Schering-Plough's Pharmacovigilance CAPA project. This effort involved
leveraging the Periodic Safety Update Reports (PSUR) generation to create
product lists and definitions for 60 products reported to the EMEA as per
the company's CAPA commitment. Responsibilities included detailed
analysis of the report requests from the user groups, checking for
technical/GDP completeness, assigning report development and coordinating
between 9 developers, 3 Operational Quality Reviewers and the business.
. Assisted with implementing Global Applications Change Control System
(GACCS) using TrackWise 6.0, to meet the SOX Objectives for tracking the
changes made to the financial systems in SOX inventory within the Global
Pharmaceutical Business Unit of Schering-Plough. Responsibilities
included architecture, configuration, project coordination, and
client/vendor liaison.
Schering-Plough Research Institute, Kenilworth, NJ
05/01 - 04/03
Applications Analyst
. Assisted with the development & implementation of Labeling Tracking
System (LTS) and Global Regulatory Affairs Commitment Tracking System
(GRA CTS), both 21 CFR Part 11 Tracking Systems, using TrackWise .
Responsibilities included architecture, configuration, project
coordination, and client/vendor liaison.
. Led the testing team during System, integration and Regression testing.
Intern / Tester
. Developed and executed test scripts for Functional, System Integration,
and Regression testing for SPRIDox V4 & Regulatory Document Management
System (RDMS), both Documentum applications.
. Recorded and tracked defects using Rational's SQA Manager Software tool.
All work performed in compliance with applicable GLP and GMP FDA
regulations.
EDUCATION: Stevens Institute of Technology, Hoboken NJ
Masters in Information Systems, Major: Computer Science
May 2002
Maharaja Sayajirao University, India
Bachelor of Science, Major: Mechanical Engineering
June 1998
OPERATING SYSTEMS AND SOFTWARES:
. Windows 9x/NT/2000/XP; MS Office 97/2000/XP; HTML, SQL Sever 2000, SQA
Manager
. TrackWise Software - TrackWise TeamAccess , TrackWise Administrator,
TrackWise Coordinator, TrackWise Migrator, Crystal Reports
. Documentum Software - GXPharma (Web and Docbase Components), Documentum
Administrator 4.3
. Publishing Software - CoreDossier Administrator, CoreDossier Assembler,
CoreDossier Generator/Server
CERTIFICATIONS & TRAINING:
. Project Management Principles
. Systems Development Life Cycle
. 21 CFR Part 11 Awareness Training / Applied Training
. Computer Systems Validation / Good Documentation Practices
. SOP Awareness Training
. FDA Inspection & Audits
. Basic Drug Development
. Certified TrackWise Administrator / Coordinator
. Certified CoreDossier Administrator 5.5.x / Publisher