Data Project

Location:

Cleveland, OH

Posted:

August 01, 2016

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Resume:

Toral Papat

+1-440-***-**** / *********@*****.***

Business Systems Analyst

SUMMARY

Over 7+ years’ experience working as a qualified Business System Analyst/Validation Analyst in the Medical Device, Life Sciences and Pharmaceutical sector.

Comprehensive knowledge of the Software Development Life Cycle (SDLC), with a thorough understanding of all phases of a project life cycle and advanced knowledge and experience working with various methodologies like Waterfall, Agile-Scrum and Rational Unified Process (RUP). Also well-versed with the change request and change control management required in SDLC.

Extensive experience in gathering, managing and documenting business and functional requirements, and creating Business Requirement Document (BRD), Functional Specification Documentation (FSD), Business Use Cases, Functional Use Cases and User stories.

Facilitated Joint Application Development (JAD) sessions/ / Joint Application Requirement (JAR) sessions and Joint Requirement Planning (JRP) sessions and Rapid Application Development (RAD) sessions with end-user/clients/stake holders and the IT groups.

Requirement Elicitation sessions which includes Interviews, Questionnaires, User Observation Workshops, Brainstorming, Role Playing and Prototyping and experience in creating User Training Manuals and Requirements Traceability Matrix (RTM).

Seasoned participant of daily Scrum meetings, Scrum planning meetings, Scrum review, and Scrum retrospective with cross-functional teams.

Creating detailed project plans assisting in developing, scheduling and tracking project timelines.

Experienced in designing UML diagrams like Context, Use Case, Sequence and Activity diagrams, along with Business Process Documentation and modeling, Work Flow Diagrams, Data Flow Diagrams, Flow Diagrams (Business and Navigation), Process Flows (Business and System).

Thorough understanding and experience in User Acceptance Testing and documentation of the formal Validation Test Plans and Protocols (TPP).

Comprehensive experience in Analysis, including GAP Analysis (As-Is and To-Be processes), remediation plans SWOT Analysis and Corrective and Preventive Action (CAPA) to deal with deviations and knowledge of Feasibility study, Root-cause Analysis (RCA), Change Impact Analysis(IA), Risk Analysis and Return on Investment (ROI).

Knowledge and experience of various Auditing roles and responsibilities in various situations with comprehensive knowledge of EDMS (Electronic Document Management System) using Documentum for handling document versions, workflows and lifecycles.

Implementation of Validation protocols like installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) which form a part of the Validation Master Plan (VMP) for HPLC, Gas Chromatography- Mass Spectroscopy (GC-MS), ultraviolet-visible spectrophotometer (UV-Vis), Atomic Absorption Spectrophotometer and Plate Reader.

Experience working in an FDA regulated environment, with excellent understanding of cGxP (cGCP, cGMP, cGDP, cGLP) and Standard Operating Procedure (SOP) and in preparing documentation which is in compliance with 21 CFR Part 11.

Detail oriented and a quick learner with a natural ability to meet deadlines and submit deliverables under minimal supervision with an exceptional ability to work as both a team player and independently with excellent communication and interpersonal skills and exceptional problem solving and sound decision making capabilities.

EDUCATION

Bachelor of Pharmacy – Mumbai University

Masters in Medical Chemistry – Long Island University

Masters in Computer Information Systems- American college of commerce and technology

PROFESSIONAL EXPERIENCE

Hospira, Lake Forest, IL

May 2014 – Present

Business Systems Analyst

Hospira is the world's largest producer of generic injectable pharmaceuticals, manufacturing generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management systems. Hospira's products are used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities.

Project: The Waters Empower 3 System will be used for laboratory chromatographic data acquisition, management, processing, reporting and distribution at Hospira Biologics Sites. The Empower 3 System will facilitate the acquisition, storage, and analysis of laboratory test data and will provide electronic data records and electronic signature management for multiple Hospira`s sites.

Responsibilities:

Analyze business processes and data to help determine how new technology can satisfy business needs.

Organize and participate in design review sessions to gather business requirements and issue resolution.

Translate business requirements into functional specification documents.

Provide business knowledge expertise in a focused area of the business by developing a keen understanding of business needs.

Under guidance of management and/or senior team members work closely with technical analyst, IT and application vendor to transform and develop design requirements throughout all phases of the project from system design to implementation.

requirements. Was responsible for user acceptance testing (UAT) of the final product.

Execution of test scripts for functional testing of Infor10 and data migration testing in Infor10 in development, validation.

Designing and reviewing different comprehensive data reports using MS Access and MS Excel.

Act as second level internal support for required applications. Take appropriate action to resolve or triage for escalation to management and development staff.

Contribute to project planning and implementation.

Track project deliverables using appropriate tools.

Present reports defining project progress, problems and solutions.

Document change requests.

Participate in requirements gathering for ongoing enhancement request.

Help facilitate user integration and acceptance testing.

Assist in creating user and training documentation.

Served as quality assurance/quality control to ensure that the final product met all the clinical protocol

Environment: Windows XP Professional, XML, Toad for oracle,SQL,MS EXCEL Query,MS Access, Infor 10, EAM 8.3, MS Excel, MS Project, RUP, Oracle, UML, VBA, MS Office suite, MS Visio.

Ohio Department of Health, Columbus, OH

April 2013 – March 2014

Business Systems Analyst

Ohio department of health is a laboratory setting for the state of Ohio to manage health care and laboratory testing.

Project: The project was about updating the New Laboratory Information Management System which was manual and needed to be automated. Processing system from manually operating system to automated operating system in order to enhance operational efficiency and care delivery.

Responsibilities:

Conducted user interviews, gathered requirements, and analyzed the requirements in developing the Laboratory Information management system.

Conducted JAD sessions with Laboratory scientists, Information technology technicians, senior research management and project team to capture business requirements and system behavior.

Documented test cases during requirements gathering, analysis and design phases.

Maintained a proactive stance with business relationship(s) to ensure the business needs are always met within GLP Quality guidelines.

Worked with the team for implementation of this project as per Lean Methodology and BABOK practices.

Worked on the Business requirement documents, User requirement specifications and functional requirement specifications documents

Prepared Report requirement documents for submission to the Centers for Disease Control and Prevention

Prepared Customized Canned and Adhoc reports by running a SQL query that provided information on attributes like laboratory tests performed, observation and results for Submission to the FBI and CDC through LIMSi.

Created workflows based on Business Process Modeling Notation (BPMN) such as activity diagrams, swim lane diagrams, sequence and state diagrams for graphic representation of the existing laboratory process as well as improvise the existing process.

Created As Is – To Be Process Mapping through MS Visio, Excel, Relational mapping, Block diagrams.

Knowledge on Trackwise to affirm audit trail / log asserting execution is done as per plan and guidelines.

Participated in full project life cycle including gathering user requirements, screen and report design, in addition to implementation and roll out.

Involved with implementation of laboratory and pre-clinical sample management softwares such as Bionumerics and Pulsenet and to increase efficiency and reduce costs.

Created SQL queries and views and used those objects to develop Canned and customized reports

Created client documentation, Standard operating procedures, work cards and work lists.

Environment: Windows XP Professional, XML, Toad for oracle,SQL,MS EXCEL Query,MS Access, Infor 10, EAM 8.3, MS Excel, MS Project, RUP, Oracle, UML, VBA, MS Office suite, MS Visio,Cognos,Sharepoint, myCIMS.

Novartis, Cambridge, MA

July 2012 – March 2013

Business Systems Analyst

Novartis Pharmaceuticals is one of the world’s leading makers of prescription and over the counter medicines, medical imaging products, nutritional products and ostomy care and modern wound care products. It has been a pioneer in pharmaceutical research and development.

Project: In the downstream labs for cancer research needed a LIMS software which could help the scientists organize their clinical trial data of Xenograft and Allograft data. This software performed sample management, and workflow management for scientists. The application was a web-based non-GXP application, whose development was done in-house.

Responsibilities:

Proactively worked with scientists in the biology research groups to understand their needs

Defined data management solution(s) to meet the research needs

Performed rapid prototyping to refine the requirements

Worked with internal and/or external software teams in different NIBR sites to design the solutions that fit into the overall application and data landscape

Understanding and building of scalable and integrated solutions to support the scientists’ work

Worked directly with the scientists to gather details required for the annotation of biological entities such as antibodies, cell lines or tissues

Requirement gathering performed for Integration of biological solutions to meet the needs of Infrastructure and scientists.

Provided support documentation and User training documentation of the a in-house developing biological solution

Worked with Web application and iOS application to define needs, upgrade to new platforms and software deployments in test, production environment.

Performed Stress test, performance testing, regression testing and UAT on a Web application- biological solution.

Served as quality assurance/quality control to ensure that the final product met all the clinical protocol requirements. Was responsible for user acceptance testing (UAT) of the final product.

Execution of test scripts for functional testing of Infor10 and data migration testing in Infor10 in development, validation.

Designing and reviewing different comprehensive data reports using MS Access and MS Excel.

Biogen Idec, Cambridge, MA

Jan 2011 – June 2012

Business Analyst/ Data Migration Analyst

Biogen is a global biotechnology company specializing in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide.

Project: Biogen Idec is re-implementing its Electronic Asset Management software EAM 8.3 to Infor 10.1.1, in order to provide fully electronic work process, simplified user interface, integration with Oracle for automatic purchasing of spare parts, analysis tools to help Biogen Idec to track costs and optimize performance and single system for both maintenance and calibration management of GMP and non-GMP equipment’s.

Responsibilities:

Responsible for defining the scope of the project, gathering business requirements, doing gap analysis and documents them textually or within models.

Responsible for writing Functional Requirement Specifications (FRS) and User Requirement Specification (URS) for the Web based application`s modules (Infor 10).

Analyst will assist in developing the data migration plan in accordance to Biogen Idec IT procedures.

Conducted JAD Sessions to develop an architectural solution that the application meets the business requirements, resolve open issues, and change requests.

Analyst will be responsible for testing Infor 10 software and Migration tools required

Conducting sample data migrations into development environment.

Analyst will be responsible to documenting the data migration plan. Data Migration Plan is required to be routed for review and approval.

Work with SME and Data scrubbing team to provide data mapping. Identify missing data source. Define verification approach and success criteria

Update migration deliverables. Evaluate and develop test bed for Data migration of GXP and non-GXP datasets.

Plan and ensure lock-down and transition strategy available during Data migration.

Identify any data fix, rework, or enhancements resulting from migration.

Assuring that all validation documentation such as Process Validation, Cleaning Validation, and Software Validation are in compliance with cGMP's.

Served as quality assurance/quality control to ensure that the final product met all the clinical protocol requirements. Was responsible for user acceptance testing (UAT) of the final product.

Execution of test scripts for functional testing of Infor10 and data migration testing in Infor10 in development, validation.

Designing and reviewing different comprehensive data reports using MS Access and MS Excel.

Amgen, Thousand Oaks, CA

March 2009 – Dec 2010

Business Analyst

AMGEN is among the world's leading Biotech companies, with multiple products on the market for serious or life-threatening medical conditions.

Project: I was playing a role of lead Business analyst in export of regulatory and clinical docments to clients and documenting this process. ECM- Lead Business Analyst for Micromet Integration project, which integrated FDA, clinical documents into Legacy server and Enterprise document management servers. I was also involved in AMG 706 migration to Takeda from Amgen. SDLC : Aglile Methodology.

Responsibilities:

Provide application and process subject matter expertise for business clients and technical resources.

Analyze technical processes with client, drafting and documenting functional/technical requirements for business systems enhancements.

Prepared Business Context Diagram, Use Case diagrams and corresponding Activity Diagrams using Rational Rose to depict the workflows to be incorporated into the development of Business Process Management (BPM) tool.

Reviewed gap analysis reports, remediation plans and Corrective and Preventive Action (CAPA) reports to track deviation handling.

Defined business rules, counts in BRD, which went through review and approval cycle.

Performed Preliminary Scoping, analyzed source documents, determine volume, complexity, redundancy, available meta-data, rules, patterns.

Created change requests and change managment of a process and document.

Analyze Target system readiness. Develop document migration approach and plans. (input to data migration plan) Created Data Migration plan(regulated document)which contained migration requirement, process flow, test cases, rollback plan.

Involved in preparation of Document Migration, by working with SME to provide document mapping spreadsheet containing metadata of the documents.

Identify missing Meta data source. Define verification approach and success criteria. Update migration deliverables. Evaluate and develop test bed.

Plan lock-down and transition strategy.

Performed Migration Testing by obtaining missing metadata. Evaluate test runs with business. Adjust mapping spreadsheet as needed.

Update migration deliverables, conducting JAD meetings with business and clients. Ensure lock down and transition.

Performed Migration Execution evaluates migration results, documents. Test and ensure lock out of legacy documents.

Experience in working with EDM systems like EPIC, EDM Quality, and EDM CRF as target systems.

Document QC and Approvals via migration deliverables(Data migration plans,requirement gathering form, Relationship mapping sheet, Mapping spreadsheet for Migration, Sign off form). Identify any data fix, rework, or enhancements resulting from migration.

Migration Closure: Complete any rework or data fixes needed. The project is signed off with Document QC and Approvals via migration deliverables.

Performed Preliminary Scoping, analyzed source documents, determine volume, complexity, redundancy, available meta-data, rules, patterns.

Completion of migration,by exporting/ importing clinical, regulatory(GXP) documents to/ from end-clients.

Identified any data fix or enhancements resulting from migration.

Extensively involved in writing Manual Test cases and User Acceptance Testing (UAT) scripts.

Created User Training Manual.

Environment: Windows XP Professional, XML, MS Access,EDM Quality, EDM CRF,EPIC, MS Excel, MS Project, RUP, Oracle, UML, VBA, MS Office suite, MS Visio.

TECHNICAL SKILLS

Programming Languages: C, C++, PL/SQL, VB, VBA, PASCAL

Operating Systems: MS DOS, MS Windows 95, 98, NT/2000, XP, 2003 and 2008 MS Windows Server edition, UNIX

Databases: Oracle 10g, 10i, MS Access, Chromatography Data Systems (CDS)

Applications: Rational Rose, MS-Visio, MS Excel, MS-PowerPoint, MS-SharePoint, Aqualogic.

Testing Tools: Win Runner, QTP, Load Runner, Test Director, Quality Center, Rational Robot, Requisite Pro, Rose, Clear Case, and Clear Quest.

Computer System Validation: 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 4, VMP, Validation Protocols (IQ, OQ, PQ), SOPs, RTM, SQL*LIMS, LabWare LIMS and Web LIMS, AERS, VSR, Audit Trials

Lab Equipments: Scanning Electron Microscope (SEM), High Performance Liquid Chromatography (HPLC), Nuclear Magnetic Resonance (NMR), Mass Spectroscopy (MS), Gas Chromatography (GC), Autoclaves, Plate Readers.

Application Packages: Enginuity PLM, Documentum, ERP MS Office (Word, Excel, PowerPoint, Visio, Project, Access), Matlab, E Drawer Meridian

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