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Contact: rruperto@paperlesspr.net Phone: 939.777.6400 Page 1
Ramón Ruperto, MBA
IT / CSV Project Manager
California address: 123 Wild Horse Drive, Novato, CA, USA 94945
Puerto Rico address: Camelot 140 Road # 842 Apt. 2101, San Juan, PR 00926-9757
Phones: 939.777.6400 E-mail: rruperto@paperlesspr.net
PROFESSIONAL PROFILE
Mr. Ruperto is fully bilingual (English/Spanish), USA Citizen, who brings to your organization over 26 years of experiences
managing a variety of Strategic Global Information Technology Systems Integration and Computer Systems Validation (CSV)
projects related to highly regulated business critical Systems (GxP) within Life Sciences Industries (Pharmaceuticals, Medical
Devices, Bio-technology, Health Care, Food and Beverage) and High Tech Electronic Manufacturing in North America, Latin
America, Europe and the Caribbean. Strong experience in Software Systems Integration to ERPs and mission critical business
strategic enterprise systems. Business Systems Analysis & Design, Project Management, Systems Development Life Cycle (SDLC),
Software Development and Systems implementation. Experience with FDA Computer Systems Validation Life Cycle (SLC).
Knowledge on (SDLC) Waterfall, Agile Methodologies, ITIL process. Performed leading roles as CSV QA Subject Matter Expert
on FDA Consent Decree (CD), CSV IT QA. Experience working on remediation projects for critical GMP systems, FDA CSV QA
Interim Controls, CSV Mentoring, Revision and Auditing of IT Computer Systems Validation deliverables. Experience supporting
IT Audits and CSV tests for Data Integrity in ERP systems exporting and importing data as a result of system integration with other
critical systems to ensure that any critical regulatory data is recorded exactly as intended into a destination media such as a relational
database or file entity for later retrieval and to ensure the retrieved data is the same as it was at the time when it was originally
recorded. Data integrity aims to prevent unintentional changes to information and it will impact Data bases, files system and data
storage, physical and logical integrity.
Mr. Ruperto has been responsible to provide overall leadership for IT Systems Integration and Computer Systems Validation
projects and be accountable for all deliverables and execution. Responsible for Capital Appropriation Request (CAR) for project
funding. Developed the strategic plans. Supported Identification of functional requirements and performance specifications.
Developed schedules, milestones, identified resource requirements, participated in evaluation of candidates, interviews and hiring
processes. Meeting with staff to discuss plans and to review status of deliverables. Monitored the progress, recognized and helped
with resolutions of technical problems. Provided regular status reports and briefings. Assured recognition of project changes and
execution of related change control procedures. Managed the project resources, including customer and contractor as required.
As a CSV SME, CSV IT QA, CSV PM/Lead, Mr. Ruperto has been responsible for the Development, Execution, Revision and
Approval of FDA Systems Life Cycle (SLC) deliverables for Computer Systems Validation (CSV): Computer Validation Plans,
Compliance Plan, Quality Plan, Testing Strategy Plan, Data Migration Plan, User Requirements, Functional and Design
Specifications, Configuration Specifications, Functional Specification Requirements (Interfaces, Conversions, Enhancements,
Reports, Forms), Data Integrity Tests, Traceability Matrix, Installation, Operational and Performance Qualifications Protocols and
Test Scripts, Business Process Master List (BPM), Release Reports, Factory Acceptance Test, Site Acceptance Test, Standard
Operating Procedures, Business Continuity Plans, Validation Plan Summary Reports. FDA 21 CFR Part 11 - ER/ES & EU Annex
11, GAP analysis, RISK Based Assessment, GMP Assessment, Remediation Plan, Close Out reports, Change Control. Full
enforcement of CSV QA Regulatory Compliance, SOPs, Guidelines and best business practices. Mr. Ruperto also has Computer
Systems validation experience in LIMS systems implementation, validation and administration. Experience includes
 IT/IM Systems, Barcoding Labeling & Data Collection Systems, High Tech Manufacturing, Supply Chain, Logistics,
Warehousing & Distribution, Quality Assurance, Laboratory Systems
 Overall implementation of the Systems Development Life Cycle (SDLC) methodology: analysis of requirements, business and
technical designs, software development, unit testing, integration testing, hardware & software installation, acceptance testing,
training, data integrity test, documentation, implementation and cut-over support.
 CSV Experience for projects using Client-Server Computing, Web Based applications, 3 tier middleware platforms
 Experience working with FDA Mandate for Consent Decree at J&J McNeil (2012-2014) & Schering-Plough (2001-2003).
 Managed implementations and computer systems validations of multinational computing systems integration projects for
Enterprise Resource Planning (ERP's) systems such as: SAP/R3, Oracle, BPCS, PRISM, JD
 Experience with IT / CSV Audits and Tests for Data Integrity in ERP systems exporting and importing data as a result of system
integration with other enterprise mission critical systems: Data bases, files system and data storage, physical and logical integrity
 REGULATIONS: USA FDA 21 CFR Part 11 ER/ES, EU Annex 11 Guidelines, USA FDA 21 CFR Part 820, cGMPs, cGLPs,
cGEPs, ISPE Baseline, CALIFORNIA ePedigree Serialization law mandate, USA SEC Sarbanes & Oxley (SOX) Financial
Regulation, GAMP 4/5 Standards, CMM Software QA, CMM, ISO 9001, ISO 13485 Medical Devices
 IT Computer Systems Integration, Computer Systems Validation (CSV) and CSV IT QA-Compliance for:

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Contact: rruperto@paperlesspr.net Phone: 939.777.6400 Page 2
o ERP Systems (SAP, Oracle, BPCS, PRISM, Data-3, MAPICS, JDEdward, HP MIMS).
o SAP CSV / PM Documentation Tools (SAP Novasol Solution Manager, SAP ICE, SAP CHARM, SAP DocNav)
o SAP/R3 Technologies - BAPI's, ABAP, RFC's, IDOCS, Modules (WMS, MM, SD, PP, PM, ICE)
o Laboratory Information Management System L.I.M.S. (HP LIMS, PC-LIMS, Syberlab, Labware)
o Mobile Systems (SAP, Syclo Agentry, Abaco Bridge, Intellitrack, Mobile Assets, Mobile OSHA)
o Compliance System (CIMCON eInfotree GMP Spread sheets Enterprise System, ComplianceWire Learning Management
System (LMS), Trackwise, EDM, SAP DocNav, Pfizer QIS) CATSWeb AssureX, Quality EtQ, Electronic Records
Management System (ERMS), Secure File Share Repository (SFRS).
o IT CSV QA documentation Tools (SAP Novasol Solution Manager, SAP ICE, SAP CHARM, SAP DocNav)
o ECMMS Engineering, Calibrations & Maintenance Management System (SAP/R3, Maximo, Procal, Calpro)
o Automated testing Tools: Rational Rose, GE Robotics, Abaco Test Analyzer
o Automated Control Systems (PLC, SCADA, OIT/HMI, DCS, BAS/BMS Honeywell, Siemens, Apogee
o Serialization Software , (Systech, Optel, Neri, Zebra printers)
o Warehousing Distribution & Logistics Systems (SAP/R3, BPCS, Data-3, HP MIMS)
o Sales Force Automation (MobileMed, Abaco Bridge – PDAs Mobile devices)
o IT Network & Infrastructure, Disaster Recovery, Backup Systems
o Hardware Platforms: HP, IBM, SEQUENT Dynix, WANG, Unix V, DEC VAX VMS, Client-Server
o Programming Languages: Pascal, Cobol, Sequel (SQL), VB, Delphi, C++, REXX, Power House
o MS Products – MS Project, Excel, Word, Power Point, Visio / Databases - Oracle, SQL, DB2, Informix, Paradox
 Achieved successful CSV Projects, including SLC deliverable, Y2K & 21 CFR Part 11 ER/ES for regulated industries
 Testing methodologies: Regression, Functional, Unit, Integration, Performance, and Load
 Experience validating Computer systems for Electronic Batch Records & Electronic Signature systems.
 Defined Quality Standards Procedures for Quality Audits, Software Controls, Software Computer Systems Validation, Software
Testing practices, Test Scripts development, execution and automated testing tools.
 Performed Risk based assessments, monitored quality events and remediation activities to ensure corrective actions comply with
regulatory standards applicable to Computerized Systems and IT assets.
 Planned, defined and supervised execution of Software testing plans and test scripts.
 Member of Corporate committees and Task Forces for Technology, Computer Validation services.
EDUCATION
 M.B.A. Global Management, University of Phoenix, AZ (2002)
 B.S.B.A. Computer Information Systems, University of PR, Mayagüez Campus (1987)
 Engineering School, University of PR, Mayagüez Campus (1982 - 1985)
IT/IM, SYSTEMS INTEGRATION & COMPUTER SYSTEMS VALIDATION (CSV) KEY PROJECTS
CSV Lead - Baxalta BioScience, Covington, GA (10/2015 – Present) - supporting the Systech Serialization Software for Track and
Trace Project for the Biotechnology product Gammagard Liquid Packaging Line 1 with integration to JD Edwards ERP. Generation
of CSV deliverables: (CVP) Computer Validation Plan, (URS) User Requirements, (FS) Functional, (DS) Design Specifications,
Design Review (DR), Configuration Specifications (CF), Risk Assessments (RA), Testing Plans, Protocols (IQ, OQ, PQ),
Traceability Matrix, CSV Reports.
CSV Lead - Gilead Sciences, Foster City, CA (08/2015 – 10/2015) – short term role to support partially an upgrade process and
validation of the IBM Maximo ECMMS software. Worked with CSV Deliverables: CVP, URS and FS.
CSV IT QA e-Compliance Manager - Novartis Alcon Division, Fort Worth, TX (10/2014- 07/15) - Responsible for the approval
of critical and strategic IT CSV compliance deliverables. Supported Global SAP ERP software implementation in Alcon Division
and Novartis organization. Enforced compliance of CSV QA SOPs, Policies, Guidelines and Standards for Alcon and Novartis.
Work closely with multiple global teams on Europe, Asia, North America and Latin America. Supported Systems Integrators, IT
personnel and coaching on CSV procedures and best business practices. Executed CSV QA eCompliance, Revision and Approval
of Strategic project deliverables: Change Requests, Release Reports, Compliance & Validation Plans, (URS) User Requirements,
(FS) Functional Specifications (Interfaces, Enhancements, Conversions), (PDLs) Project Deliverable List, (DS) Design
Specifications, Testing Plans, Protocols (IQ, OQ, PQ), Traceability Matrix, CSV Reports, (BPMs) Business Process Models, (BPDs)
Business Project Deliverables, SOPs, CSV Assessment 21 CFR Part 11 ER/ES, Annex 11), SAP Transport Approval Reports.
CSV QA SME (Subject Matter Expert) - McNeil Johnson & Johnson - Fort Washington, PA (11/2012-08/2014) –Working on
behalf of FDA as part of the FDA Third Party Quantic LLC for the CSV & Interim Controls Team on the Consent Decree Work

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Plan. Quality Systems Element (QSE) 06 VALIDATION –VL-09 COMPUTERIZED SYSTEMS REMEDIATION & VL-08
SPREADSHEETS REMEDIATION Initiatives for divisional three (3) sites: Lancaster, PA, Las Piedras, PR and Fort Washington
Home Office, PA. Supported multiple CSV projects, of highly regulated enterprise corporate and divisional systems. This included:
Secure File Share Repository (SFRS), EtQ QA Compliance, Labware LIMS, eInfotree Enterprise System, MS Excel and multiple
comma separated value (CSV) Spreadsheets, Electronic Records Management System (ERMS), ComplianceWire Learning
Management System (LMS). Also, responsible for CSV mentoring, documentation revision and auditing against J&J McNeil
Divisional CSV SOP’s and Guidelines and Johnson & Johnson ITS Division CSV SOP’s and Guidelines, as part of the supporting
activities on CD Plan. Responsible for the generation of Letter of Review (LOR), Interim Controls Review Records (ICRR), Right
First Time (RFT) Tracker Records to J&J McNeil CSV QA Management Team to ensure compliance with CSV policies, SDLC
methodology, standards, guidelines and SOP’s for all CSV deliverables. Revised and approved Compliance Plans, CSV Plans,
Compliance Analysis, URS, FS, DS, Compliance Protocols, IQ, OQ, UAT test scripts protocols, Business Process Test Plans, Data
Migration Plans, Training Plans, Retirement Plans, Business Continuity Plans, Traceability Matrix, CSV Summary Reports, SOPs,
Risk Assessments, 21 CFR Part 11 ER/ES Assessment and GAP Analysis.
CSV Lead - Bausch & Lomb, Tampa, FL (05/2012-08/2012) – short term project supporting the Systech Serialization Software for
Track and Trace for the ophthalmic cream product on packaging line 3 with integration to SAP ERP. Generation of CSV
deliverables: CV Plan, URS, FS, 21 CFR Part 11 ER/ES Assessment and GAP Analysis.
CSV Project Manager - AstraZeneca, Canóvanas, PR (01/2010-05/2012) - Working on multiple projects: SAP/R3 PM Mobile
Fixes and Enhancements Project – Syclo Agentry PM Mobile (CVP, Risk Based Assessment, : 21 CFR Part 11 ER/ES, GAP
Analysis, URS, FS, DS, IQ, OQ, SOPs, Data Integrity, CVP Report), Preventive Maintenance Module, SAP/R3 Shelf Life Lot
Expiration, SAP/R3 Planning PET Report procurement, SAP/R3 Transactions CSV Audit Documentation Revision (CVP, URS,
FS, DS, IQ, OQ, SOPs, ICR Tech Evaluation), ECMS Enhancements.
System Integration Project Manager - PepsiCo, Cidra, PR (10/2008-01/2009) - BPCS on the AS/400 computer / MAXIMO CMMS.
Lead activities related to software analysis, design, development, testing, system integration, training, SOPs, validation and
implementation.
CSV Regional Project Manager - Bristol Myers Squibb Puerto Rico Region (4 Sites) (01/2005-06/2007) – Performed Computer
Systems Validation (CSV) activities for the Technical Operations IM Group on Corporate Initiatives (21 CFR Part 11 ER/ES
Remediation) & Computer Systems Validation Risk based assessment. They include systems that supported the Parenteral/Bio-
Technology and Oral Solid dosage (OSD) areas. Enterprise systems included SAP/R3, Maximo, EtQ QA Compliance, Labware
LIMS, CalPRO. Deliverable: 21 CFR Part 11 ER/ES, GAP Analysis, CVP, URS, FS, DS, IQ, OQ, PQ, Traceability Matrix, SOP's
and Commissioning among others.
System Integration Project Manager - Solectron/Hewlett-Packard, Aguadilla, PR (05/2005-06/2006) – Lead team on all SDLC
activities and deliverables based upon SLC methodology for the implementation of wireless Data Collection and Bar Coding System
for the Warehouse and Manufacturing modules SAP/R3 (SD, MM, PP). Lead activities related to software analysis, design,
development, testing, system integration, training, SOPs, validation and implementation.
CSV Project Manager - Amgen, Juncos, PR (10/2003-03/2004) – Lead on CSV activities for manufacturing and laboratory systems
based upon SLC methodology and 21 CFR Part 11 ER/ES regulation as part of the Epogen & Neupogen biotechnology new products
expansion. Deliverables: CVP, URS, FRS, IQ, OQ, SOPs, Traceability Matrix and CVP Report.
CSV Project Manager - Medtronic, Humacao,PR (03/2003-01/2004) - Lead revision of CSV SOPs and business practices for all
Embedded Software products used in Cardiologic devices as part of a medical device operation following 21 CFR Part 11 ER/ES
and 820 regulations.
CSV Project Manager - Wyeth Co., Guayama, PR (07/2002-02/2003)– Lead on CSV activities based upon SLC methodology and
21 CRF Part 11 ER/ES regulation for Honeywell Building Automation Systems (BAS) implementation for Effexor, Rapamune and
Protonix new products expansions. Deliverables: CVP, URS, FRS, FAT, SAT, IQ, OQ, SOPs, Traceability Matrix and CVP Report.
CSV Project Manager - Merck Sharp & Dohme, Arecibo, PR (02/2002-06/2002) - Lead on CSV activities based upon 21 CRF
Part 11 ER/ES regulation and development of Remediation Plan for the implementation of Sieber Labs Laboratory Data Repository
Storage System to be intregrated with LIMS system. Deliverables: CVP, 21 CFR Part 11 ER/ES, GAP Analysis, Risk based Analysis,
URS, FRS, IQ, OQ, SOPs, Traceability Matrix and CVP Report
CSV Project Manager - Schering-Plough, Manatí, PR (04/2001-05/2003) - Lead on CSV activities based upon SLC methodology
and 21 CRF Part 11 ER/ES regulation during the Consent Decree Remediation Initiative for CSV for deliverables for Siemmens
Building Management System Apogee, and HVAC Control Systems. Deliverables: CVP, 21 CFR Part 11 ER/ES, GAP Analysis,
Risk based Analysis, URS, FRS, FAT, SAT, IQ, OQ, SOPs, Traceability Matrix and CVP Report.

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CSV Project Manager - Pfizer Corp., Vega Baja, PR 2001-07/2001) – Lead on CSV activities based upon SLC methodology
and 21 CRF Part 11 ER/ES regulation for the Implementation of a new In-House Quality System for Electronic Signature and
approval of documents and process flows. Deliverables: CVP, 21 CFR Part 11 ER/ES, GAP Analysis, URS, FRS, IQ, OQ, SOPs,
Traceability Matrix and CVP Report.
CSV Project Manager – Pfizer Corp., Fajardo, PR (06/2002-09/2002) - Lead CSV activities based upon SLC methodology and 21
CRF Part 11 ER/ES regulation for the Implementation of Waters Millenium Chromatography Systems. Deliverables: CVP, URS,
FRS, IQ, OQ, SOPs, Traceability Matrix, CVP Report.
Systems Integration Project Manager - Vishay Inter-Technologies - Corporate Strategic Supply Chain & Logistics Global Project,
(7 Sites: USA, Israel, UK, Germany) – (02/2000-04/2001) - Lead team based upon SLC methodology and 21 CRF Part 11 ER/ES
and 820 regulations for the implementation of Mobile wireless Data Collection and Bar Coding System for the Warehouse and
Manufacturing modules SAP/R3 (SD, MM, PP). Lead activities related to software analysis, design, development, testing, system
integration, Data Integrity, training, SOPs, CSV Validation and implementation.
Systems Integration Project Manager - Coca-Cola, North America SAP/R3 Supply Chain & Logistics Global Project, Fountain
Division, Corporate Facilities (5 Sites: Atlanta, GA, Dallas, TX, Columbus, OH, Ontario, CA, Lehigh Valley, PA) North America
Distribution Centers (02/1999-01/2001) – Lead team on SLC methodology and CSV practices for the implementation of Mobile
Computing Data Collection System for the Warehouse and Manufacturing modules SAP/R3 (WMS, SD, MM, PP, PM). Lead
activities related to software analysis, design, development, testing, system integration, Data Integrity, training, SOPs, validation
and implementation.
Systems Integration Project Manager - Coca-Cola Bottling Global SAP/R3 Supply Chain & Logistics Roll Out (Argentina,
Mexico, USA (03/1999-11/2000) - Lead team based upon SLC methodology and CSV practices for the implementation of Mobile
wireless Data Collection and Bar Coding System for the Warehouse and Manufacturing modules SAP/R3 (WMS, SD, MM, PP,
PM). Lead activities related to software analysis, design, development, testing, system integration, Data Integrity, training, SOPs,
validation and implementation.
Systems Integration Project Manager - Monsanto Nutrition Nutra-Sweet Division – San Diego CA, Tulsa, OK, USA, UK, Ireland
(05/1998-02/1999) – Lead team based upon SLC methodology and CSV practices for the implementation of Mobile wireless Data
Collection and Bar Coding System for the Warehouse and Manufacturing modules SAP/R3 (WMS, SD, MM, PP, PM). Lead
activities related to software analysis, design, development, testing, system integration, Data Integrity, training, SOPs, validation
and implementation.
Systems Integration Project Manager - Monsanto North America Searle Pharmaceutical Division - Skokie, Elk Grove, USA,
Caguas, PR (03/1997-04/1998) - Lead team based upon SLC methodology and CSV practices for the implementation of Mobile
wireless Data Collection and Bar Coding System transition from PRISM AS/400 Warehousing and Manufacturing transactions to
SAP/R3 (WMS, SD, MM, PP). Lead activities related to software analysis, design, development, testing, system integration, Data
Integrity, training, SOPs, validation and implementation.
Systems Integration Project Manager - Merck Sharp & Dohme, Arecibo, Barceloneta Caguas, PR (Pharmaceutical, Chemical
Plant & Veterinarian (06/1995-03/1997) – HP MIMS MRP Manufacturing, Distribution, Packaging Lines Shipping Labels Verifiers
systems. Lead activities related to software analysis, design, development, testing, system integration, Data Integrity, training,
SOPs, validation and implementation.
Systems Integration Project Manager - Abbott Chemicals, Barceloneta, PR (02/1995-03/1996) – BPCS MRP Manufacturing and
Warehousing transactions. Lead activities related to software analysis, design, development, testing, system integration, Data
Integrity, training, SOPs, validation and implementation.
Systems Integration Project Manager - Abbott Diagnostics, Barceloneta, PR (07/1994-02/1995) – MAPICS MRP Manufacturing
and Warehousing transactions. Lead activities related to software analysis, design, development, testing, system integration, training,
SOPs, validation and implementation.
Systems Integration Project Manager - General Electric (ED&C Division) - Corporate Strategic Supply Chain project (28 Sites:
PR, Mexico, USA (05/1993-06/1995) – WMS Bar Coding & Data Collection - MAPICS, BPCS to SAP/R3. Lead activities related
to software analysis, design, development, testing, system integration, Data Integrity, training, SOPs, validation and implementation.
Systems Integration Project Manager - GlaxoSmithKline, Cidra, PR (08/1993-04/1994) - BPCS Manufacturing and Warehousing
transactions. Lead activities related to software analysis, design, development, testing, system integration, Data Integrity, training,
SOPs, validation and implementation.

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Systems Integration Project Manager - Baxter Healthcare, Añasco, PR (06/1992-07/1993) – Univox Cardiovascular Blood Filter,
Purifier Oxygenator – Travel Card Manufacturing System automation. Lead activities related to software analysis, design,
development, testing, system integration, Data Integrity, training, SOPs, validation and implementation.
DAY & ZIMMERMANN VALIDATION SERVICES, Philadelphia, PA 2001 – 2004
Associate Director, Technology Validation Services, East Coast USA, Caribbean and Latin America
Responsible for the development, administration and supervision of the Computer Systems Validation (CSV), & Automation
Consulting Programs. Managed a Team of 45 CSV Validation Consultants in USA and PR offices. Responsible for all CSV projects
and deliverable such as: Computer Validation Plans, User Requirements, Functional and Design Specifications, Factory Acceptance
Test, Site Acceptance Test, Installation and Operational Qualifications, Traceability matrix, Standard Operating procedures, CSV
Summary Reports, FDA 21 CFR Part 11 - ER/ES Assessment, GAP analysis, Risk based assessments and Remediation plans.
Member of Corporate committees and Task Forces for Technology, Computer Validation services, Education, Business Contingency
Plans. Supported regional offices in USA for CSV regarding computer systems validation projects. Performed Project Planning,
Scheduling, Resources Allocation and Budget Control.
ABACO MOBILE - Atlanta, GA 1992 – 2001
Project Director, Systems Integration – North America & Latin America
Managed a team of six (6) Project Managers and 30 consultants in USA and PR offices in Software Development and Systems
Integration projects with mobile computing with Middleware 3-tier integration software products. Managed implementations and
computer validations of integration projects for Enterprise Resource Planning (ERP's) systems such as: SAP/R3, Oracle, BPCS,
PRISM, JD Edwards, Data 3, HP MIMS. Responsible for the management, mentoring and supervision of Project Managers,
Team Leaders, Systems Consultants, Computer Systems Validation Staff, budget and control of assigned software integration and
Computer Systems Validation projects. Evaluated and recommended implementation strategies and methodologies for SDLC
process flows and computer systems validation. Interacted with Customers and Project Managers to ensure Systems Integrations
projects are performed according to requirements, business and technical designs and functional specifications. Responsible for
overall implementation of the SDLC methodology: analysis of requirements, business and technical designs, software development,
unit testing, integration testing, hardware & software installation, acceptance testing, training, documentation, implementation and
cut-over support.
QA Manager, Systems Integration (Software Products & Quality Operations)
Managed a team of 12 Software Testing & QA engineers in USA, Netherlands and PR offices. Defined Quality Standards Procedures
and Computer Systems Validation (CSV) strategies and deliverables for regulated GxPs projects. Performed Quality Audits,
Software Controls and Software Testing practices, including Test Scripts and Automated testing tools. Planned, defined and
supervised execution of Software testing plans and test scripts. Supported CSV audits from clients in the Regulated Industries.
Performed overall administration of Quality projects, operations and initiatives, including mentoring, supervision, and management
of Quality department’s resources. Facilitated communication across organization and departments to encourage and embrace a
culture of quality in all aspects of the business operation. Lead Quality Systems initiatives for ISO 9001, CMM, TMM and TQM.
Performed Risk based assessments, monitored quality events and remediation activities to ensure corrective actions comply with
regulatory standards applicable to Computerized Systems and IT assets.
KEY TRAINING – LIFE SCIENCES REGULATED INDUSTRIES
 L.I.M.S. Systems Implementation, Administration, Validation & Auditing, Computer System Validation FDA System Life
Cycle (SLC), FDA 21 CFR Part 11 ER/ES Regulation, Medical Devices Regulation - 21 CFR Part 820, GAMP 4/5 Standard /
ISO 9001 Quality standards, CMM, OSHA, FDA and EPA regulations FDA Systems Life Cycle (SLC) and Deliverables
 EU Annex 11 Computerized System Validation, Computer Systems Validation - Software QA & IT Audit, Inspection of
Computerized Systems in Drug Processing, Computer Systems Validation - Network Infrastructure, Project Management
Course (5 months) - MBA Program, ASQ Quality Control Engineer Academia Certification Course (5 months)
 Computer System Validation, IT and GxP Training Curricula programs at: Baxalta. Gilead Sciences, Novartis, Alcon, McNeil
Johnson & Johnson, AstraZeneca, GlaxoSmithKline, Abbott, Schering-Plough, Johnson & Johnson Cordis, Amgen, Wyeth,
Bristol-Myer Squibb, GlaxoSmithKline, Merck, Monsanto, Integra Neuro-Sciences, Medtronic, Pfizer, Bausch & Loms, Baxter,
Vishay Technologies, Coca-Cola Corp., PepsiCo, General Electric, HP, Mallinckrodt,
 J&J Training Curricula McNeil OTC Division related to Office of Consent Decree.
 Schering-Plough Training Curricula related to Office of Consent Decree, Manufacturing Equipment & Process Controls Systems
 Administration of the Computerized QC Assay System and Testing Profiles System, Pharmaceutical Manufacturing Equipment
 Current Good Manufacturing Practices (cGMP's), Current Good Laboratory Practices (cGLP's), Current Good Documentation
Practices (cGDP).