Swarna Reddy

** ******* ****

Plainsboro, NJ ****6

609-***-****

SUMMARY:

•Validation/Compliance Specialist with more than ten (10) years of experience, with a background in Pharmaceutical, Telecommunication and Manufacturing domains.

•Excellent Business Analysis and communication skills coupled with the ability to handle multiple functions.

•Good understanding and knowledge of the Pharma industry and regulatory trends related to validation processes.

EDUCATION:

CE Technical Institute, 1997

Certificate in Oracle and Visual Basic

Georgian Court College, 1987

B.S. - Business Administration - Minor - Finance

Pursuing MBA-Finance and Information Systems (38 credits achieved)

TECHNICAL SKILLS:

Oracle Financial Applications 10.7: NCA, GL, AP, AR; Oracle RDBMS 7.3 – 9.2, SAP R3, IBM PC and compatibles, Windows NT/95, Microsoft Office (Word, Excel, Access, PowerPoint), FoxPro for Windows, Symphony, Lotus 1-2-3

ACCOMPLISHMENTS:

3/4/13 – 10/31/16:

Validation Lead: Bristol Myers Squibb, Princeton, NJ 08536

Participated in Client Review testing of the Field Force Automation software/hardware. Wrote the business cases (test scripts) that applied in the actual testing by utilizing the following resources: written business requirements, interactions with the business organization or business client. Document results, track and investigate issues, and assist in the creation of all required testing documentation, specifically Test Plans, Test Scripts, and Test Summary Reports. Work with other members of the Field Force Management team to ensure that a quality product is deployed.

Complete all required pre & post-testing documentation in compliance with 21 CFR Part 11 guidelines, documenting standard operating procedures (SOPs) and methods that meet compliance and systems validation requirements surrounding the testing of new Pharmaceutical Sales Force Automation hardware upgrades or new software releases.

06/2009 – 12/2/12: ITS Johnson and Johnson, Raritan, NJ

Lead Compliance Officer / Quality Assurance Lead and Validation Specialist Lead

Reviewed various qualification activities, including GXP and SOX compliance regulations.

Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system. Review validation deliverables for projects which are contracted to third party suppliers

•Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

•Assist in planning, implementing, and documenting user acceptance testing

•Reviewed existing validation document packages and identified gaps and compliance recommendations

•Reviewed and approved the IOQs in according to SOX guidelines

•Reviewed SOP’s and Work Instructions as needed.

•Reviewed executed System Test Scripts

•Coordinated with the QA Validation and Development Team for Defect Resolution

•Created various status reports for maintenance of the Review and Build Tickets generated by ITSM/BMC Remedy System

•Maintained close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

•Assisted in planning, implementing, and documenting User Acceptance testing

•Provided guidance on quality issues that affect the integrity of the data or the system

•Participated in establishing standard quality and validation practices (system validation, drug validation)

•Independently assessed compliance practices and recommended corrective actions

•Approved validated computer system related change requests

•Reviewed computerized systems validation documents such as:

•Requirements Specification

•Test Plans

•Test Summary Reports

•Pre/Post Executed Test Scripts

•Traceability Matrix

•Release to Production Statements

•IQ, OQs

•Explanation for gap in employment: actively seeking next opportunity

05/2006-08/2008 Bristol-Myers Squibb, Princeton, NJ 08536

Validation Specialist/UAT for SAP Analyst

•Maintained the database for the ROTC Project and determined ways to organize and store data

•Created, tracked, updated and maintain Remedy tickets as needed

•Maintained tester and developers’ data for management review

•Provided functional support for customized SAP reports.

•Developed SQL queries to access Oracle database for customized SAP reports

•Ran audit reports to see and monitor users’ activity

•Completed Ad Hoc request by business partners using TM1, Holos, Oracle Financials and SAP reports

08/2004-04/2006 Interco PSGA Johnson and Johnson, Bridge Water, NJ

System Analyst

•Responsible for ‘Sarbanes–Oxley Audit Test for Finance Department.

•Maintained authorizations according to individual and departmental needs

•Prepared and reviewed federal and state actual and hypothetical relocation tax returns.

•Involved in special projects as needed for Finance, Treasury and Travel & Expense departments

•Prepared custom financial reports using Oracle Financials and SAP

Explanation for gap in employment: actively seeking new opportunities

03/1998-12/2003 Bristol-Myers Squibb, Princeton, NJ

Validation Specialist, Systems Analyst, March 1998 to Dec 2003:

•Provided support and analysis to senior management, including business and strategic plans, projections and actual performance results and communicated these results in appropriate formats

•Delivered quality and timely information to support GBS senior management

•Responsible for monthly balance sheet reconciliations

07/1995-03/1998 Bellcore Communications, Piscataway, NJ Finance and Systems Analyst

•Provided functional support for Oracle Financial Applications

•Developed FSG Reports and balance sheets for multiple locations according to the needs and requirements

•Utilized Microsoft Office, FoxPro for Windows and other financial packages such as Holos and NPAMS

•Developed corrective financial transactions ensuring compliance with corporate policies and procedures

•Prepared financial data for internal funding shifts and flexes

Explanation for gap in employment: actively seeking new opportunities

08/1987-09/1994 Phiillips Lighting Corporation, Somerset, NJ Finance and Systems Analyst

•Performed analysis of monthly expense reports and restructuring reports for manufacturing locations in five states

•Responsible for real estate and personal property tax analysis for all manufacturing locations within United States and Canada

•Reduced tax liability for state audits significantly through better planning, organizing, and remaining abreast of changing state tax laws and identified source of six figure annual losses through research and analysis

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