Oracle Manager

Senior Application & Business Analyst / Validation Project Lead

Qualifications Summary: Administrative support professional experienced

working in fast-paced environments demanding strong organizational,

technical, and interpersonal skills. Trustworthy, ethical, and discreet,

committed to superior customer service. Confident and poised in

interactions with individuals at all levels. Detail-oriented and

resourceful in completing projects, able to multi-task effectively. Over 15

years of progressive data processing experience, of which have been in a

technical leading role. Nine years into the electronic manufacturing

environment (FCC Regulation) and eight years at medical device

manufacturing environment (FDA Regulations, GxP, GMP, LIMS, ISO) have

giving me key positions in well known Fortune 500 such as Motorola and CIBA

Vision (a Novartis Branch). Bilingual (English and Spanish).

Proven Record - Across all Major Manufacturing Functions: I am skilled in

all manufacturing functions and with computers integrated manufacturing

applications in which built a premier distribution network, develop time

studies to improve manufacturing line processes, provide tools for

management, improve performance of scrap tracking cost and develop/enhance

SOP's and goals to be aligned with Corporate.

Technical Skills: Knowledge base scale from 1 to 10

o Relational Databases: Oracle/7/8i/9i/10g (7), SQL 2000/2005 (6),

Access (5)

o Tools: Stored Procedures (7),, Import/Export (7), Oracle Enterprise

Manager (OEM) (7), Oracle Forms and Reports 6i/9i/10g (8), Business

Objects (5), Developer 6i and 2000 (6), Oracle Developer Suite 9i and

10g (8), DDL (8), Oracle Application Server(7), DML (8), Oracle Loader

(SQL Loader) (7), Visual Studio 2003/2005/2008 (6), MS SQL 2000/2005

(6), T_SQL (6), MS SQL Enterprise Manager (5), TSO, CICS, VSAM

o Languages: SQL (7), PL/SQL (7), TSQL (6), 4gl, VB .Net (6), VBA(5),

some ASP. Net (4), some Java (2), Pascal, Cobol, RPG

o Software: Visio, Ms Office, Lotus Notes, MS Project, Helpdesk

Management Systems (Tigerpaw)

o Networking: TCP/IP, IPX/SPX, SMTP, SNA, and FTP.

o OS: Windows 2000/2003 server (5), NT (3), XP (7), some Unix (3), some

Linux (3), some Mac (3), OS 390 mainframe

o Software Development Methodologies: Waterfall (SDLC) (7), RAD (6),

Agile (5), Prototyping (6)

o Document and processes development: User requirements (7), functional

specifications (7), design specifications (7), UML (6),

Configuration/Release Management (7), Security Management (6),

Workflow Process (6), Incident and Problem Management (7), IT Service

Continuity Planning/Business Continuity (Disaster Recovery Plan) (6),

Maintenance and Problem logs (6), Risk Assessments (7), GAP Analysis

(6), Software Retirement Plans (7)

o Analysis/Design Methods: Data Flow Modeling (7), Business Modeling

(7), Process Flow Modeling (7), Conceptual Design (7), Business

Process Mapping (7)

o Frameworks Knowledge: Information Technology Infrastructure Library

(ITIL), Project Management, Capability Maturity Model (CMM), Process

Maturity Framework (PMF)

QA / Validations Skills

o Document development: Validation master plan, IQ, OQ, PQ, test plan,

test scripts, summary reports, change controls, change requests, IT

quality manuals, quality metrics, SOP, Trace matrix, Gap Analysis,

Risk Assessment, incident reports, remediation activities report

o Knowledge of: GxP, GMP, LIMS, 21 CFR 820 Quality System Regulation, 21

CFR 11 Electronic Records/Electronic Signature, 21CFR 58 Good

Laboratory Practice for non Clinical Laboratory Studies, ISO9000,

Corrective Action Preventive Action (CAPA), complaints, Document

Control, Purchasing Control, Process Validations, Labeling and

Packaging Control, Device Master Record, Device History Record, Record

Retention

o Validation Studies: Retrospective, concurrent and prospective

o Software Validation Experience: Empower (Master Plan, IQ, OQ, PQ using

HPLC-GC), WIP Control Software (in house application), Peoplesoft PLTP

Module, Servers, LAN/WAN, Calibration Manager, Lens meters

Instruments, FG Label software, MP2, Instrumentation, Software

Migration, Oracle Database Migration, Finish Goods Label

Consolidation, Sterilization Machine (SBM)

o Trainings: Quality System Global Standard and Requirements ( The

Quality System Inspection Technique: 'QSIT' ( General Enforcement and

Draft Civil Money Penalty Policy ( 21CFR11( Manual and Automated

Software Testing ( Test Director Software (QTP Basic & Advanced

International Experience: My career has given me the opportunity to

provide and gain experiences in different countries such as Singapore,

Japan, Australia, China, Panama and Dominican Republic by providing

software development/project leader role, ERP implementer role and

validation processing role.

BBA - Major in Computer Science - University of Puerto Rico

Training: Project Management (PMI), Time Management, Six Sigma, Lean

Manufacturing, TCS, TQM, Kaizen

Certifications - Oracle PL/SQL and FORMS in process

Professional Experience

CIBA Vision (Novartis Subsidiary) - IT Technical Specialist /Validation

Project Leader/Contractor From 1998 to present

o Analysis, design and development (Full SDLC) of the following in house

applications using Oracle and MS SQL 200/2005 databases and tools for

internet/intranet architecture;

. Automated Labeling for FG (VB.net 2005(Crystal Report) and

Oracle Forms & Reports)

. Adapt ZPL (Zebra Technology) barcode system to Visual Studio

2005 and (Oracle Forms and Reports (RDF and JSP))( (Crystal

Report)

. WIP process (Oracle Forms and Reports (RDF and JSP),

Discoverer))

. Inventory Control (Oracle Forms and Reports (RDF and JSP),

Jdeveloper)

. BOM (Oracle Forms and Reports (RDF and JSP))

. MRP2/3 (Oracle Forms and Reports (RDF and JSP))

. Distribution (for USA, Canada, Japan, Singapore, Europe)

(Oracle Forms and Reports (RDF and JSP), Jdeveloper)

. Scheduler

. CAPA and complaints module (Oracle Forms and Reports (RDF and

JSP))

. Training Application System to interact with the Corporate

Knowledge Management System created in Oracle (Oracle Forms

and Reports)

. Security module for all the in house application development

(Oracle Forms and Reports (RDF and JSP))

. Creates and develop manufacturing statistics using Oracle

Forms, Oracle Reports, some Oracle Discoverer charts

(Automatic daily yields by product, Daily shipments, Backlog,

Environment and humidity control alarms versus product

performance, Product performance, Material usage and disposal

statistics, Quality metrics, Manufacturing Process Time

Studies, Receiving, Incoming Inspection and transfer to WIP

process time studies and statistics)

. QA and Manufacturing Statistics for Management (VB.net 2005,

SQL Server 2000/2005)

. Shop Floor Control (original VB.net 2003 migrated to VB.net

2005)

. CIM (VB.net 2005)

o Analysis, design and development for a new made to order product SCM:

The programming for the Distribution, Warehousing, picking process and

inventory for a new made to order product was developed to improve the

SCM project for it. The product required printing the language

corresponding to each of the countries to be distributed, specifically

for the Europe and Asia community. Peoplesoft ERP could not provide

this kind of flexibility. The ERP Order Management module was

configured to maintain the country which the order was made and the

manufacturing routings from the ERP was used. After the product was

finished, the system provides BIN process in which the Peopleosft ERP

system could obtain inventory information.

o Installation, setup and implementation of an ERP software for Finance

and Distribution in Japan (MS SQ7) The need for Japan to have a

Financial and distribution module capable to handle their business was

requested by Japan to Corporate. I was assigned to install and setup

MS SQL7 and the ERP software from Australia. Consultants from

Australia were part of my team for the implementation.

o Improvement to Japan SCM: Time studies and routing analysis was made

to improve the Distribution to Japan. An IT infrastructure and

software were developed which improve 20% of the shipments to Japan.

The paperwork was delivered immediately to the Japan port authority

and the inventory was transfer to the Japan database. Also, because

of Japan requirements, assembly and documentation of the product was

improved.

o Analysis, design and development of Suppliers Performance application:

Statistics, status and progress report system was developed according

to the suppliers SOP. As been regulated by FDA, suppliers need to be

monitored. The statistics included were quantity delivered, shipments

and quality. All of them by weight and percentages.

o Installation, setup, validation and maintenance of Oracle Enterprise

Database and Application Server 9i: The application Server 9i was

setup to be the metadata repository for the in house development to

provide data efficiency for quality improvement, maximize the

manufacturing process and the primary tool for management. Since this

is a small to medium database environment, the tasks to be performed

to the Oracle database were made by one person only. The following

were the tasks performed;

o Installing Oracle software

o Creating Oracle databases

o Starting up and shutting down the database

o Managing the database's storage structures

o Managing users and security

o Managing schema objects, such as tables, indexes and views

o Making database backups and performing recovery when necessary

o Proactively monitoring the database's health and taking

preventive or corrective action as required

o Some monitoring and tuning performance

o Managing the Application Server (Forms & Reports configuration,

job scheduling, statistics report, startup services)

o Migration to Oracle Enterprise Database and Application Server 10g:

All applications, tablespace, tables, views, indexes, users and

security measurements were migrated from Enterprise Application Server

9i to Application Server 10g.

o IT Project Leader for Peoplesoft implementation PLTP Module: The

Peoplesoft implementation was a global effort between all CIBA Vision

sites. The PLTP module implemented had a various interfaces because

of the needs to maintain the manufacturing process flow applications

already in place. Analysis, gather requirements and design

specifications and data models for the interfaces was the job

incurred. Also, the implementation of infrastructure for Peoplesoft

and the Shop Floor Control Application were executed in timely manner.

o Oracle Forms and Report migration: All applications developed in

Oracle Forms and Reports 6i were migrated to Oracle Forms & Reports

9i. Then to Oracle Forms & Reports 10g.

o Installation, setup and maintenance of a Data Warehouse in

SQL2000/2005 server: The interfaces developed for the Statistics

Application were the input/output of the MS SQL server database. The

Data Flow modeling and the Conceptual model were used to design and

implement this process.

o VB6, VB.Net 2003/2005/2008, ASP. Net, SQL, T-SQL internet/intranet

architecture: Shop Floor Control, Automated Labeling, CIM, statistics,

FG Labeling adapting ZPL (Zebra Technology) barcode system

o Stored Procedures, SQL, T-SQL, views: Automatic daily yields by

product, daily shipments, backlog, environment and humidity control

alarms versus product performance, product performance, material usage

and disposal statistics, quality metrics, manufacturing process time

studies, Receiving/Incoming Inspection and transfer to WIP process

time studies and statistics.

o RS232 connectivity using VB .net: Application to acquire contact lens

measurements and stats from the Marco lens meter equipment (

Application to acquire data from analytical balances at the Analytical

Laboratory for the LIMS project ( Application to control 2 alarms for

the sterilization process ( Application to add functionality to the

backlight controller of a wet cell (different light intensity

according to the requirements of the product to test)

o Interfaces development to extract, transform and load data (ETL) from

Peoplesoft ERP to local Oracle database and MS SQL 2000/2005: The ETL

processes were developed by creating manually stored procedures,

import/export processes, database links and job scheduling. The

interfaces for the Oracle database were developed using PL/SQL

database stored procedures, queries and views. For the SQL2005

database, the interfaces were created with SQL and T-SQL stored

procedures. Data was collected from the Corporate ERP (Oracle 9i),

the local manufacturing database (Oracle 9i/10g) and the statistic

server (MS SQL 2005). Statistics were updated according to

criticality of the process. Some statistics were updated every 15

minutes, others each hour and in a daily basis. Management and

manufacturing process was able to perform more adequately with

customers improving Supply Chain by 12%.

o Modeling method applied: Unified Modeling Language (UML) has been the

modeling language for the Business Modeling, Process Flow Modeling and

Data Flow Modeling using a conceptual design for all the in house

development making this the standard documentation for the validation

process and for the development team. Software development

methodologies used were Waterfall (SDLC), Agile and RAD.

o Sarbanes-Oxley implementation for IT (IT SOX): IT SOX was implemented

in various aspects on systems. Finance and IT requirements were

produced for this purposes establishing benchmarking across functional

areas. Some of the implementation made were the High Level Risk

Assessment for system software, analysis/design/implementation of Raw

Material Specification checklist for Receiving Department using PDA's,

the software and data security Risk Assessment and implementation

process, and enhancement made to provide Finance Department with a

cross reference between system transactions and financial

investigations reports.

o E-Business Suite: Assessment to migrate Oracle Peoplesoft ERP

Inventory and Distribution and from the local Oracle database data to

the Oracle E-Business Suite Inventory and Warehouse Management module.

Assessment to migrate data from the Oracle Peoplesoft ERP Purchasing

and Supplier module to the Oracle E-Business Suite Procurement module.

o FDA and BSI Audits: Participate in 2 FDA audit and 1 BSI audit in

which in one FDA audit, three validations were challenged and passed

with no issues. The critical one was the Waters Empower software,

where product process was altered since the GC's were added to the

Empower software functionality.

o Qualification and Validation Program: Develop and maintain the local

Qualification and Validation program for software and align all

software quality manual and SOP's with Corporate guidelines. This

project was a worldwide effort to consolidate and structure the

Software Qualification and Validation program.

Consultant/Contractor - Project Leader for GM Group and Advance Computer

Technology - From 1994 to 1998

o GM Group: Analysis, design development and implementation of an Oracle

database for an in house application to the PR Government Employee

retirement plan. (4 programmer analysts and 1 DBA using Forms and

reports)

o Advance Computer Technology: Software pre-sales support (Platinum

Technologies software, utilities for Oracle databases)

Motorola - System Programmer / Developer / IT Manager - From 1986 to 1994

o Install and implement the OS390 operating system as System Programmer

(mainframe)

o Analysis, development and implementation of an application for BOM,

Scheduler and WIP, Payroll and HR systems as Application and Data

analyst

o Consolidate 5 computer center facilities in one central

administration.

o Team Development Specifications and implementation of Flux Soldering

robotics

o Implement Total Customer Satisfaction and Six Sigma philosophy in non-

manufacturing areas

o Six Sigma projects

o Design and implement manufacturing flow for Micro Chips Needle

Insertion robotics

o Design and Implement robotics for R&D facilities in PR

o Analysis, Design and Implementation of WIP Control

o Implement Oracle Financials

Other Skills

Contract and Negotiation Experience: LAN and phone system wiring (budget

325k 15% under budget) ( Infrastructure migration to Cisco Networking, Unix

servers, and Windows servers ( Outsourcing resources (consultants,

validation professionals, system analysts/programmers, etc) ( Computers and

software standardization and licensing (Leasing proposal) Budget 600k 10%

under budget) ( Contract negotiation for WAN/LAN monitoring and

troubleshooting ( SLA's and Service Desk contract

Resources Managed: CIBA Vision - 2 developers, 2 system administrators, 2

-6 for special projects, 0 -5 for validations projects (Budget 1.2 M) (

Motorola - 3 Manager, 17 computer/electrical/mechanical engineers, 4

mainframe operators, 6 system analyst/programmers, 1 system programmer and

1 DBA (Budget 2.9 M) ( Consultant/Contractor - 4 developers, 20 data

entries, 2 project leader, 1 technical writer (Budget 750k)

Business Function Knowledge: Budget preparation, Budget Control, Capital

Requests, Manufacturing process, WIP, Manufacturing Inspection, QA

Inspection, Incoming Inspection, Receiving, Shipping, Planning, Cycle

Count, Cost Control, Warehouse, Distribution, Packaging, Yields, Cost

Rollup, Inventory Control, BOM structure, MRP 2 and MRP 3, Purchasing, Line

Balancing, Lean Manufacturing, forecasting, P & L, Internal Controls,

Payroll, HR, Backlog, Environment and humidity control, product

performance, Material usage and disposal statistics, Quality metrics,

Manufacturing Process Time Studies, Robotics

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