Confidential, New Jersey
Environment: Sparta Systems’ TrackWise, NextDocs Regulatory Document Management
- Planned, executed, and documented TrackWise upgrade from 7.0.3 to 8.3.2, including the installation of TrackWise, Crystal Reports, and supporting applications.
- TrackWise 8 and Crystal Reports 12 configuration and debugging, ConfigForms changes, setup user accounts and permissions, configuration migration, prepared testing environment, and license management.
- Performed TrackWise 7 configuration changes and created reports for Complaints, Change Request, Supplier/Vendor Management, Audit, Observations, and Corrective and Preventive Action (CAPA) workflows.
- Using TrackWise Migrator, moved configuration changes from Development environment to Quality,, and Production environments.
- Performed data uploads using the TrackWise import utilities.
- Supported import/export interfaces with SAP system.
- Gathered and analyzed business requirements to optimize process workflows.
- Created User Requirements/Functional Requirements, Traceability Matrix, PQ, PQ Summary Reports, Work Instructions, executed PQ, documented/processed deviations.
- Validated NextDocs (SharePoint based) Regulatory Document Management and Promotional Copy Review systems.
Environment: Sparta Systems’ TrackWise, Oracle, FDA regulated systems, cGMP, 21 CFR Part 11 (Electronic Record and Signature) systems
- Obtained TrackWise from Sparta Systems.
- Worked with Sparta consultant in requirements gathering and analysis.
- TrackWise and Crystal Reports configuration to implement Compliance, QA, Facility Information, Helpdesk and 21 CFR Part 11 assessment workflows on an Oracle database backend.
- Prepared and executed validation test plans, hardware and software IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification).
- Led requirements analysis and design discussions with the customers and IT developers.
- Performed requirements analysis by conducting interviews with project customers and created the user requirement, design and hazard analysis documents.
- Prepared 21 CFR Part 11 assessments, risk analysis, remediation and compliance plans.
- Validated and deployed support group incident management software for a regulated environment.
- Assisted in writing the change control and complaint handling procedure for a regulated user environment.
Confidential, New Jersey
Environment: Sparta Systems’ TrackWise, cGMP, 21 CFR Part 11 (Electronic Record and Signature)
- Prepared and executed the Installation Qualification, Operational Qualification, and Performance Qualification for validating ConvaTec’s Global Corrective and Preventive Action (CAPA) workflows implemented using Sparta Systems’ TrackWise 6 application.
- Developed the Migration Installation Qualification to document the migration of the TrackWise configuration from the development environment to the test environment, and from the test environment to the production environment.
- Developed PQs for validating 21 CFR Part 11 requirements, and conducted assessments for 21 CFR Part 11 compliance.
- Created the IQ/OQ plan, and Requirements Traceability Matrix.
- Helped develop the Validation Plan, Master Validation Plan, Functional Requirements, and Project Plan.
Confidential, New York
Environment: Systech Serialization and Product Tracking, Weiler Bottle Labeler, Pester Case Packer with Case Labeler, Pester Palletizer, IMA Print and Inspect Machine
- Provided computer system validation/equipment qualification services for Packaging End of Line Serialization and Product Tracking project based on the Systech SPT Solution.
- Created and updated validation documentation including Qualification Plan, Failure Mode and Effects Risk Analysis (FMEA), User Requirements, Functional/Design Specifications, and Traceability Matrix.
- Created Site Acceptance Tests, IQ/OQ/PQ Qualification Protocols, and Test Summary Reports.
Confidential, New Jersey
Environment: SAP ERP Central Component, SAP Solution Manager, HP Quality Center
- Using SAP Solution Manager, performed quality review and approval of User Requirements, System Requirement Specifications, Configuration Specifications, and Test Summary Report documents for global implementation of SAP ECC 6.0.
- Using HP Quality Center, reviewed and approved test scripts (pre and post execution) and the associated defects following BD Software Development Lifecycle (SDLC).
- Worked with onshore as well as offshore teams from Capgemini.
- Created and updated User Requirements, System Requirement Specifications, System Design Specifications, Configuration Specifications, Traceability Matrix, and Test Summary Reports for global implementation of SAP ECC 6.0.
- Conducted risk analysis on user and system requirements for SAP ECC project.
- Performed remediation activities based on audit findings.
Confidential, New York
Environment: LabWare Laboratory Information Management System (LIMS), Waters Chromatography Data Acquisition System (CDAS) Empower 2, Waters LAC/E32 Acquisition Systems, CyberLAB Knowledge Engineering System, Rockwell Automation PMX Manufacturing Execution Systems (MES), Honeywell Experion PKS R210, GE Kaye LabWatch Data Acquisition System, Siemens APOGEE Building Management System, Proficy Portal, Proficy Historian, Documentum GXPharma/WebCache, Quality Control Biological Investigation Tracking System
- Prepared the Risk Assessment, Revalidation Plan, Technical Architecture, Site Configuration Specification, Site Traceability Matrix, Regression Tests, Performance Qualification (PQ), and Protocol Summary Reports, and Revalidation Report for Wyeth Release 12 of LabWare LIMS.
- Validated the GE Kaye LabWatch Data Acquisition System (DAS) and Siemens APOGEE Building Management System (BMS) used to control and monitor the Class 100,000 Grade D environment of a sterility testing lab. Responsibilities included the day - to-day project management, creation of the Validation Plan, User Requirements, Migration Plan, Traceability Matrix, Test Protocols (IQ/OQ/PQ), and Validation Summary Reports.
- Validated the Honeywell Experion PKS R210 system used to control and monitor a vaccine production facility. Prepared the Validation Plan, Risk Analysis, User Requirements, Migration Plan, Traceability Matrix, and Validation Summary Reports. Prepared and executed the IQ, Operational Qualification (OQ), and PQ.
- Prepared the Risk Assessment, Revalidation Plan, and PQ for Wyeth Release 11 of LabWare LIMS.
- Created the IQ, IQ Summary Reports, Decommissioning Plans, Decommissioning Reports, Data Migration Plans for Waters LAC/E Acquisition Servers and CyberLAB system.
- Prepared the Validation Plan, Risk Analysis, Installation Qualification, Performance Qualification, and Validation Summary Reports for the Documentum GXPharma/WebCache document management system.
- Validated the Data Historian System based on GE’s Proficy Portal and Proficy Historian applications following Wyeth’s Computer Systems Validation Lifecycle procedures.
- Rockwell Automation PMX Manufacturing Execution Systems (MES) author . Created PMX MES workflow test scripts and PQ protocols.
- Proficy Portal, Proficy Historian, and Waters CDAS Empower 2 administrator .
- Prepared the Periodic Review, Revalidation Plan, and Revalidation Report (Instrument Connection) for the Waters Empower Build 1154 (CDAS) system.
- Created the Disaster Recovery Plans for the CyberLAB and Empower CDAS systems.
- Created and executed the IQ/OQ for Wyeth’s Quality Control Biological Investigation Tracking (QBIT) system.
Confidential, Addison, Texas
Environment: Pharmaceutical Supply Chain/Logistics, cGMP, DEA, 21 CFR Part 11 (Electronic Record and Signature)
- Performed retrospective validation of IBS’ ASW/Rx Pharmaceutical Supply Chain/Logistics application; including the warehouse, distribution, customer service, and finance modules.
- Performed gap analysis and created the remediation plan.
- Prepared validation plan, user requirements specifications, IQ/OQs, system architecture, acceptance tests, and validation summary documentation.
- Created validation documents for Aldon revision control system and ICS Data Warehouse system.
- Conducted assessments for 21 CFR Part 11 compliance and documented evaluation results.
- Prepared and executed validation test plan and protocols.
- Developed System Development Life Cycle (SDLC) procedures.
- Created and updated ICS Standard Operating Procedures.
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