PROFESSIONAL PROFILE:

• IT Business Systems Analyst professional who brings to your organization over 26 years of experiences as CSV QA Compliance, CSV SME, Project Manager and Lead Consultant managing a variety of Strategic Global Computer Systems Validation (CSV) for Software & Hardware, Information Technology (IT), Data integrity (DI), and Systems Integration projects related to highly regulated (GxP) and critical enterprise Information Technology (IT) business Systems within Life Sciences Industries: Pharmaceuticals, Medical Devices, Bio - technology, API Chemical Plants, Research & Development (R&D), Health Care, Food and Beverage. Broad experience in High Tech Manufacturing, Warehousing, Supply Change, Logistics, Distribution, Marketing, Human Resources, Engineering & Laboratory systems. Validated enterprise applications in CRM, ERP, MRP, LIMS, ECMMS, EDM, QA, EBR.
• As FDA CSV IT QA SME, CSV IT QA eCompliance Manager, Data Integrity Lead, CSV IT Project Manager/Lead, experience in the Development, Execution, Revision, Approval and Auditing 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, Data Integrity Audits, Data Integrity Strategy Plan, (URS) User Requirements, (FDS) Functional and Design Specifications, (CS) Configuration Specifications, (FRS) Functional Requirements Specifications (Interfaces, Conversions, Enhancements, Reports, Forms), Data Integrity Tests, Traceability Matrix, (IQ) Installation, (OQ) Operational and (PQ) Performance Qualifications Protocols, (UAT) User Acceptance Test, Validation Plan Summary Reports, IQ, OQ, PQ Summary Reports.
• Lead, executed and audited FDA 21 CFR Part 11 ERES and EU Annex 11 assessments, GAP analysis, Risk Based Assessment, Use Cases, Test cases, Process Flows. Experience reviewing and aproved CSV & IT QA CAPAs investigations & resolutions, Business Process Master List (BPM), Release Reports, (FAT) Factory Acceptance Test, (SAT) Site Acceptance Test, (SOPs) Standard Operating Procedures, (BCP) Business Continuity Plans, (GTR) General Technical Report (GTR. Strong experience in Systems Integration and Computer Systems Validation (CSV) for ERP / MRP systems (SAP, Oracle, JD Edwards, PRISM, Data 3, BPCS, MAPICS), Compliance systems (Trackwise, EDM, QIS, LMS, eInfoTree), Laboratory (LIMS) systems. Experience in Software Quality Assurance, (SDLC), Waterfall, Agile, ITIL, GAMP 4/5 methodologies. Experience performing IT/CSV Audits for Data Integrity. Experience working on 21 CFR Part 11 ERES and EU Annex 11 remediation and upgrade projects for critical GxP systems, FDA CSV QA Interim Controls, CSV Mentoring, Revision and Auditing of IT Computer Systems Validation Life Cycle deliverables. Computer Systems validation experience in LIMS implementation, validation and administration.
• As Senior GxP Business Systems Analyst, lead CSV initiatives for execution of FDA 21 CFR Part 11 and EU annex 11 compliance. Acted as liaison with the business and other IT groups to coordinate Computer Systems Validation for Software and Infrastructure hardware Qualification, and the delivery of entreprise and strategic GxP Information Technology solutions to meet business needs.
• Experience in Software Systems Integration to ERPs, MRPs and CRMs. Experience with Software Systems Development Life Cycle (SDLC and Agile Methodologies.
• Expertise in providing functional process analysis, requirements, QA testing, FDA Computer Systems Validation (CSV) and documentation of new and existing GxP business applications and processes.
• Experience performing business systems analyst functions to include: project definition, analysis of requirements, systems design, development, testing, validation, user training, and implementation.
• Proven ability gathering customer requirements and translated them into IT functional specifications.
• Areas of focus included: Data Analysis, Business Process Re-Engineering, Standard Business Reporting, Data Visualization, Data Mapping, System Interfaces and FDA Computer Systems Validation Life Cycle (SLC).
• Provided application, process, and end user support. Prepared and maintained project related documents and FDA GxP deliverables such as: project scope, Project Plans, CSV Plan, Test Strategy & Quality Plan, URS, FRS, DD, IQ, OQ, UAT/PQs test scripts, SOPs, Traceability Matrix, Summary Reports. Interacted with internal and external customers to better understand capabilities related to project work. Participated in the overall process improvement of functional areas within and across applications. Support CAPAs IT & CSV investigations, Manufacturing, Distribution, Warehousing and Logistics, document conversion to images with OCR technology, mobile computing, Electronic Batch Records (EBR), Manufacturing Travel Card (MTC), barcoding data collection, software and systems integration, electronic signature capturing, biometric systems, Client-Server Computing, Web Based applications, 3 tier middleware platforms.
• As CSV IT Project Manager, managed Information Technology (IT) and Computer Systems Validation (CSV) projects using the FDA System Life Cycle (SLC) methology. Lead CSV assessments for FDA 21 CFR Part 11 ERES and EU Annex 11 compliance.
• Managed Software Development and Systems Integration projects using System Development Life Cycle (SDLC) phases. This role included the administration of project’s financial, technical resources, direct communication and negotiation with client’s top management. Interacted with IT Vendors and consultants responsible for the technical solution: software, equipment, system.
• Acted as liaison between all key players for a project: Business and Process Owners, IT, QA, Laboratories, Manufacturing, Packaging, Engineering, Technical Services and others.
• Provided governance support for cross-functional planning, budgeting and resourcing activities, functional requirements and performance specifications. Developed schedules, milestones, identified team resource requirements (FTE). Meeting with project’s stakeholders to discuss plans and to review status of progress and deliverables. Worked closely with 3rd party technical vendors. Monitored the progress of the project, review and discuss technical issues and participate in problem resolution to minimize impact on planned tasks. Overall experience includes:
• Enforced compliance of REGULATIONS: USA FDA 21 CFR Part 11 ER/ES, EU Annex 11 Guidelines, USA FDA 21 CFR Part 820, 211, 212, cGMPs, cGLPs, cGEPs, Data Integrity, ISPE Baseline, CALIFORNIA ePedigree Serialization law mandate, USA SEC Sarbanes & Oxley (SOX) Financial Regulation, GAMP 4/5 Standards, HIPAA Compliance, CMM Software QA, CMM, ISO 9001, ISO 13485 Medical Devices.
• Performed Risk based assessments, FDA 21 CFR Part 11 ERES & European Annex 11 Assessments for GxP and Strategic Business Critical systems in Manufacturing, Warehousing, Logistics, Distribution, Packaging, Engineering, Laboratory, Finance & Accounting, Human Resources, CAPA and Documentations systems.
• Implemented FDA Systems Life Cycle (SLC) waterfall, agile and V-Model methodologies for CSV activities.
• Performed IT / CSV QA Audits, CSV CAPAs investigations and Data Integrity Tests for enterprise GxP applications.
• Planned, defined and supervised execution of Software testing plans and test scripts.
• Experience with testing methodologies for: Regression, Functional, Unit, Integration, Performance, and Load.
• Implemented 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.
• Defined Quality Standards Procedures for Quality Audits, Software Controls, Software Computer Systems Validation, IT infrastructure Hardware Qualification, Data Integrity, Software Testing practices, Test Scripts development, execution and automated testing.
• Monitored quality events and remediation activities to ensure corrective actions comply with regulatory standards applicable to Computerized Systems and IT assets.
• Managed Systems Integration Mobile Computing Data Collection and Computer Systems Validations projects for multinational Enterprise Resource Planning (ERP's) systems: SAP/R3, Oracle, BPCS, PRISM, and JDE.
• CSV SME for FDA Mandate for Consent Decree Programs at Johnson & Johnson Confidential and & Schering-Plough.
• Validated Computer systems for Electronic Batch Records (ERB) & Electronic Signature systems.

TECHNICAL SKILLS:

ERP Systems: SAP, JDE, Oracle, BPCS, PRISM, Data-3, MAPICS, HP MIMS

SAP Tools: SAP ICE Project Life Cycle Methodology, SAP Novasol Solution Manager document control, SAP Document Navigator (DocNav), SAP CHARM Change Management Control

Compliance System: CIMCON eInfotree GMP Spread sheets Enterprise System, Software as a Service (SaaS) ComplianceWire Learning Management System (LMS), Trackwise, EDM, Confidential QIS, Quality EtQ, Electronic Records Management System (ERMS), Secure File Share Repository (SFRS).

SAP/R3 Technologies: BAPI's, ABAP, RFC's, IDOCS, Modules (WMS, MM, SD, PP, PM, ICE) ECMMS Engineering, Calibrations Maintenance Management System SAP/R3, Maximo, Procal, Calpro

Laboratory Information Management System (LIMS): PC-LIMS, Syberlab, Empower, Labware, LIMSMAC

CRM: Salesforce.com Software as a Service (SaaS), Veeva, Siebel, Salsa.

Asset Management Systems: (SAP Syclo, Maximo, Blue Mountain, A-Bridge, Intellitrack, PSI Mobile Assets)

Automated testing Tools: HP QC ALM Testing Tool, Rational Rose, GE Robotics, Abaco Test Analyzer

Serialization Software: Systech, Optel, Neri, Zebra printers

Sales Force Automation: MobileMed, Abaco Bridge - PDAs Mobile devices, Industrial tablets, cel phones.

Automated Control Systems: PLC, SCADA, OIT/HMI, Honeywell BAS PlantScape, Siemmens BMS Apogee

IT Network & CSV Infrastructure Qualification: Servers, switches, wireless backbone, mobile computers (PDA, industrial Tablets), backup and archiving Systems (Informatica), biometric input devices, 2D scanners, barcode printers (Zebra, Intermect, Datamax, Bar Tender), Easy label & Label Design software products

Programming Languages: Pascal, Cobol, Sequel (SQL), VB, Delphi, C++, REXX, Power House

PROFESSIONAL EXPERIENCE:

Confidential, Dallas/Fort Worth, TX

Global CSV IT QA e-Compliance Manager

Responsibilities:

• Responsible for partnering with IT-IGM to conduct Data Integrity and compliant computer systems validation process for Global Strategic IT Enterprise Business Systems in the 34 countries of the EMEA Region and North America, which includes: Global IRIS Program (SAP ERP Systems), Global enVision program (CRM systems: salesforce.com, Veeva, Salsa, JDE, Seibel), Integration Project IRIS-enVision, Integration Project JDE-SAP ERP’s, Global HR ILearn system, HP QC ALM Automated Testing, Informatica Data Archiving, APL-Pharma Integration, Shape PI-SAP Technical Upgrades, Data Migration & Export (GSK, Elanco, and Sequirus), IT enterprise systems retirement.
• Executed CSV Assessments for FDA 21 CFR Part 11 ERES and EU Annex 11, CSV QA eCompliance, Revision and Approval of Strategic project deliverables using SAP CSV / PM Documentation Tools (SAP Novasol Solution Manager, SAP ICE, SAP CHARM, and SAP DocNav). Documents included: Change Requests, Release Reports, Compliance & Validation Plans, Quality Plan, (URS) User Requirements, (FS) Functional Specifications (Interfaces, Enhancements, Conversions), (PDLs) Project Deliverable List, (TOL) Tests Overview List, (DS) Design Specifications, Data Migration plans, Data Integrity protocols, Testing Plans, IQ, OQ, PQ Protocols, Traceability Matrix, CSV Reports, SAP Transport Approval. CSV & IT QA CAPAs investigations & resolutions.
• Assured compliance to applicable GXP requirements and Novartis / Alcon SOP’s during the implementation of SAP (IRIS) ERP and enVision (CRMs) Global systems. Identified requirements for compliant computerized operations and suggested methods for identification, implementation, maintenance of procedures and actions to assure compliance according to FDA and European regulations).
• Reviewed and approved CSV System Life Cycle (SLC) documents related to IRIS (SAP ERP) and enVision (CRM’s) global programs validation, deployment, implementation and hypercare. Managed change management control process for realization and implementation phases. Managed activities related to the development and implementation of GxP/CSV and eCompliance areas of the IT and QA policies, quality manuals, standards and procedures. Provided guidance to assure that Alcon GxP-relevant IT systems & Infrastructure are in compliance with Quality Modules and applicable regulations.
• Reviewed and aproved CSV & IT QA CAPAs investigations & resolutions regarding strategic GxP & mission critical enterprise business systems. Worked closely with QA, IT, Process Owners and key team’s members to conduct a compliant computer systems validation process for all applicable GxP applications. Executed reviews and approval of Data Integrity, CSV System Life Cycle (SLC) eCompliance deliverables, Change Request (CR’s) and Change Documents (CD’s) process. Supported approval of HP ALM QC proton (e-testing) Working Instructions, Global Operation Procedure for Global OneCSV program within Novartis Alcon. Review of SDL Corporate CSV templates.
• Oversight, Control and Approval of all activities related to Computer System Validation (CSV), electronic records and signatures, to ensure GxP-compliant implementation and maintenance of global deployed strategic IT systems.

Confidential

CSV Data Integrity & FDA 21 Part 11 ERES Lead Auditor

Responsibilities:

• Short term assignment to support FDA CSV GMP Data Integrity & GMP CSV 21 CFR Part 11 ERES Compliance Audit project. Lead FDA CSV GMP Data Integrity and 21 CFR Part 11 ERES assessments, and supported teams working with GxP and Strategic enterprise business systems used at: Quality, Manufacturing, Packaging, Warehousing, Supply Chain, Logistics, Engineering, Laboratories, Accounting & Finance, Information Technology.

Confidential, Covington, GA

CSV Lead

Responsibilities:

• Lead CSV activities for the Systech Serialization Software for Track and Trace Project for the Biotechnology product Gammagard Liquid Packaging Line 1 with integration to Oracle JD Edwards Enterprise One (E1) ERP. Executed assessment for FDA 21 CFR Part 11 ERES and EU Annex 11 compliance.
• Developed the CSV Strategy Plan for validation of the system, computerize components and IT infrastructure, Software Modules, Packaging and Re-Packaging stations, Vision systems, EPCIS Serialized number repository, interfaces to ERPs in SAP and Oracle ERPs. Worked with the following CSV deliverables for Systech Guardian Module: (CVP) Computer Validation Plan, (URS) User Requirements, (FRS) Functional Requirements, Data Integrity protocols, (DCS) Design & Configuration Specifications, Design Review (DR), and Traceability Matrix.

Confidential, Foster City, CA

CSV Lead

Responsibilities:

• Research and Development (R&D) and Clinical Trials. Short term assignment to support the review of URS and the development of CSV Validation Plan for IBM Maximo ECMMS & Assets Management software.

Confidential, Fort Washington, PA

FDA CSV IT QA SME (Subject Matter Expert)

Responsibilities:

• Reviewed and approved FDA System Life Cycle (SLC) deliverables: Compliance Plans, CSV Plans, Compliance Analysis, URS, FS, DS, Data Migration Plans, Data Integrity tests, IQ, OQ, UAT test scripts, Business Process Test Plans, Data Migration Plans, Training Plans, Retirement Plans, Business Continuity Plans, Traceability Matrix, CSV Reports, Risk Assessments, 21 CFR Part 11 ERES Assessment & GAP Analysis.
• Responsible for CSV IT QA Audits: review and approval of FDA System Life Cycle (SLC) deliverables and 21 CFR Part 11 ERES and Data Integrity assessment for Confidential corporate and divisional GxP and enterprise IT business systems.
• This included: Secure File Share Repository (SFRS), eInfotree Enterprise System for MS Excel (CSV) Spreadsheets, Trackwise, EDM QA Regulatory Compliance systems, Electronic Records Management System (ERMS), Software as a Service (SAAS) ComplianceWire Learning Management System (LMS), SAP ERP, EtQ Compliance, Labware, LIMSMAC Laboratory Information systems (LIMS), Manufacturing Execution Systems (MES).
• Responsible for the review and approval of FDA Audit documents: Letter of Review (LOR), Interim Controls Review Records (ICRR), Right First Time (RFT) Tracker Records to Confidential & Confidential CSV QA Management Team to ensure compliance with CSV policies, SDLC methodology, standards, guidelines and SOP’s for all CSV deliverables
• Performed and aproved CSV & IT QA CAPAs investigations & resolutions regarding strategic GxP & mission critical enterprise business systems. Performed CSV Audits, provided mentoring, and reviewed and approved FDA CSV Systems Life Cycle deliverables as per Confidential Divisional SOP’s and Guidelines and Confidential & Confidential ITS Division CSV SOP’s.

Confidential, Tampa, FL

CSV Lead

Responsibilities:

• Short term assignment supporting the validation of 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, and executed FDA 21 CFR Part 11 ERES Assessment and GAP Analysis for packaging systems.

Confidential, Canóvanas, PR

CSV PM / Lead

Responsibilities:

• Lead CSV activities and executed FDA 21 CFR Part 11 ERES and EU Annex 11 assessments, GAP Analysis, Risk-based assessments, CVP, URS, FS, DS, IQ, OQ, PQ, Trace Matrix, Data Migration Plans, Data Integrity test, SOP's.
• Supported SAP PM Mobile Fixes and Enhancements Project - Syclo Agentry PM Mobile, SAP PM Preventive Maintenance Module, SAP Shelf Life Lot Expiration, SAP Planning PET Report, SAP MM, SAP CSV Audit Revision (CVP, URS, FS, DS, IQ, OQ, SOPs, ICRs), CMS Enhancements.
• Managed multiple CSV projects: Validation of Trackwise EDM Compliance System, CSV Software Validation and Hardware Infrastructure Qualification of SAP Syclo Calibration, SAP PM, SAP Plant Assets Management.
• Supported transition from paper based work orders to paperless system with electronic signatures for a number of 100+ users in Engineering & Maintenance department using mobile handheld computers

Confidential, Puerto Rico

Regional CSV PM

Responsibilities:

• Corporate CSV Compliance and FDA 21 CFR Part 11 Remediation Initiatives for the PR Region.
• Lead FDA 21 CFR Part 11 ER/ES Assessments and Remediation initiatives for Computer Systems Validation (CSV) activities at four manufacturing facilities. Assessed GxP systems in Parenteral/Bio-Technology and Oral Solid dosage (OSD) areas.
• Lead CSV activities & deliverables: 21 CFR Part 11 ER/ES, GAP Analysis, Risk based assessments, CVP, URS, FS, DS, IQ, OQ, PQ, Traceability Matrix, Data Migration Plans, Data Integrity, SOP's and Commissioning, development of Capital Appropriation Requests (CAR) and remediation plans for all PR Region
• Worked closely with 3rd party vendors for the CSV remediation. Enterprise systems included SAP/R3 ERP, Maximo ECMMS, Trackwise EDM, EtQ QA Compliance, Labware LIMS Empower laboratory, Blue Mountain Asset Management, CalPRO. Electronic Batch Records (ERB) & Electronic Signature systems.

Confidential, Aguadilla, PR

Systems Integration CSV PM / Lead

Responsibilities:

• Business Analysis, Design, Development, Implementation and CSV Software Validation and Hardware Qualification of Mobile Computing Data Collection System for the Mfg. & Warehousing modules SAP ERP (SD, MM, PP).
• Business Analysis, Design, Development, Implementation and CSV validation, including 21 CRF Part 11 ERES of Mobile Data Collection System for Maximo ECMMS 5.2 and SAP Syclo Smart, Work Manager, Inventory Manager.
• Lead CSV activities and performed 21 CFR Part 11 ERES assessment of MFG and LAB systems at Epogen and Neupogen biotechnology products.

Confidential, Humacao, PR

CSV PM / Lead

Responsibilities:

• Lead Revision and updates of CSV SOPs, Confidential System Validation Methodology (MSCM) and business practices for all Embedded Software products used in Cardiologic devices as per compliance for FDA 21 CFR Part 11 ERES and 820 regulations.
• CSV validation and 21 CFR Part 11 ERES compliance for Honeywell PlantScape Building Automation System (BAS) and Manufacturing Execution System (MES) implementation for Effexor, Rapamune and Protonix products.
• CSV validation and FDA 21 CFR Part 11 ERES compliance, Data Integrity of Sieber Labs Laboratory Data Repository Storage System integrated with LIMS system.
• CSV validation and 21 CFR Part 11 ERES compliance of during the Consent Decree Remediation Initiative for Trackwise EDM, Siemmens Building Management System (BMS) Apogee, Data Historian.

Confidential, Vega Baja, PR

CSV PM / Lead

Responsibilities:

• CSV validation and 21 CFR Part 11 ERES compliance for MAPS QA EDM System for Electronic Signatures.
• Global SAP ERP Supply Chain & Logistics project
• Business Analysis, Design, Development, Implementation, CSV Software Validation and Hardware Qualification, Data Integrity of Mobile Computing Data Collection System for Mfg. & Warehousing SAP ERP (SD, MM, PP).
• Business Analysis, Design, Development, Implementation, CSV Software Validation and Hardware Qualification, Data Integrity of Mobile Computing & Data Collection System for the Mfg. & Warehousing modules SAP ERP (WMS, SD, MM, PP, PM).

Confidential

Systems Integration CSV PM / Lead

Responsibilities:

• Business Analysis, Design, Development, Implementation, CSV Software Validation and Hardware Qualification, Data Integrity of Mobile Computing Data Collection System for the Mfg. & Warehousing modules SAP ERP (WMS, SD, MM, PP, PM).
• Business Analysis, Design, Development, Testing, Implementation and CSV Software Validation and Hardware Qualification, Data Integrit of Mobile Computing Data Collection System for HP MIMS MRP Mnfg. & Warehousing (WMS).
• Business Analysis, Design, Development, Testing, Implementation, CSV Software Validation and Hardware Qualification, Data Integrit of Mobile Computing Data Collection System for BPCS & MAPICS MRPs Mfg. & Warehousing transactions (WMS).