Engineer Quality
Resume:
Email: ***********@*****.***
OBJECTIVE:
To obtain a leading position in the field of Quality Assurance /Computer Systems Validation/QA-Software Testing with a progressive company that will utilize my expertise and offer an opportunity for growth and advancement.
SUMMARY:
Over 10 years of experience in Information Technology as a Quality Assurance Professional leading and performing Computer Systems Validation efforts, Quality Assurance efforts on Computer Systems, Quality Assurance analysis and Software Testing efforts in various industries including but not limited to Pharmaceutical, Biomedical, Life Science, Finance, etc.
Experience working on systems like Regulatory (International Regulatory Information System), Clinical (Oracle Clinical, ClinTrial, Clinical Data Management System, Sample Tracking, Anonymization, CAPA), Laboratory (LIMS, ADMIN LIMS, LIMSWare), Manufacturing, Material Management, Data acquisition & Reporting system (Compliance Early Warning System) in Life Science Industry, Recruit Management system and Billing system in Financial Industry etc.
Experience in supervising staff members/testing team, Leading and/or coordinating validation projects, providing technical leadership, assisting in technical interviews, preparing project proposals; authoring software development and Validation deliverables and reviewing project deliverables for technical content and overall quality as a Quality Advisor within QA/Quality Control group, developing project documentation (Quality Plan, Validation Strategy Document (VSD), Validation Assessment Report (VAR), Compliance Strategy Document (CSD), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Requirements Traceability Matrix (RTM), Standard Operating Procedures (SOPs), Validation Summary Report (VSR) etc.) and reviewing deliverables for technical content and overall quality and also providing Production and System Test Support and training.
Knowledge about software life cycles, Vendor Audit, compliance/QA & 21 CFR Part 11 assessments, requirements gathering and analysis, and software testing.
Aware of 21 CFR Part 11, good clinical practices (GCPs); good laboratory practices (GLPs) and current good manufacturing practices (cGMPs) for computerized systems to comply with FDA standards and regulations.
Experience in providing advice and guidance on applicable regulations and internal corporate policies
Good oral, written and interpersonal skills.
Self-starter, team player, and an individual contributor and can handle multiple priorities & determined to get quality work done within time and budget.
Self-made, confident, creative and motivated person, having a proactive and goal oriented approach.
Quick problem-solver, strong analytical skills.
Desire to continuously learn new skills.
COMPUTER SKILLS:
Language: C, C++, Visual Basic 6.0, H, Shell, HTML, SQL* Plus.
Database: Oracle 8i, Access 2.0.
Operating Systems UNIX, OS/2, MS Windows NT and 95, DOS, Sun SPARC,
and Environments: Macintosh, IBM PC, FTP, and Familiarity with TCP/IP.
Software and Tools: ORACLE, SQA Navigator 4.1, Crystal Reports, Test Director 7.0, WinRunner 7.2, SQA SUITE 6.0, Silk, Microsoft office, IE, Netscape.
TECHNICAL TRAININGS, SEMINARS:
Life Science Industry GxP Training, cGMP Training, Applied GCP Training, GLP Training,
Specific Training: Millennium32/Empower Training, LIMS Training, Computer Systems Validation Training, 21 CFR Part 11 Advanced Training, MRL Record Management Training, Documentum, E*docs Document Management System, Adverse Experience Reporting Seminar, Drug Development Life Cycle Seminar.
EDUCATION:
B.S. in Physics, The Maharaja Sayajirao University of Baroda, India (May, 1996)
D.S. in Computer Science, International School of Computer Technology, India, (June, 1998)
Diploma in Automated Software Testing, Comet Technology, NJ (August, 1999)
Associate degree in Software Engineering, Middlesex County College, NJ, (December, 2000)
ACCOMPLISHMENTS:
Paragon Computer Professionals, NJ
Validation/QA Lead/Manager (03/05 – 11/09)
Responsibilities:
Manage individual assignments by providing technical leadership for testing and Validation activities for the pharmaceutical industry. Assist in preparing project proposals; develop project documentation and review deliverables for technical content and overall quality as a Quality Advisor for the team.
Individual Assignments:
Client: Bristol Myers Squibb Co. – Hopewell, NJ
Validation/QA Lead/Manager (03/05 – 11/09)
Lead and conduct computer system validation effort for a data repository based system called IRIS (International Regulatory Information System). IRIS is a validated global data repository for tracking regulatory filings and approval/marketing statuses of company’s medicinal products around the world.
Gather requirements, design tests for the requirements, author test scripts, execute test scripts, review executed testing.
Supervise team of system testers and user acceptance testers regarding test process including documentation and error handling.
Coordinate and schedule all computer validation activities.
Author validation documents such as Quality Plan, Validation Plan, Release Plan, Traceability Matrix for various testing phases, Summary reports, etc...
Designed Validation process, Life Cycle Model for a validated computerized system and Documentation Completion Dependencies guidelines for the project team.
Provide extensive experience in validation activities and validation strategy, and excellent coordination skills in order to validate this Global data repository product.
Taratec Development Corporation, Bridgewater, NJ
Validation Specialist/Quality Assurance Test Engineer (10/00 – 03/05)
Responsibilities:
Manage assigned projects, provide technical leadership and participate in testing and Validation activities for the pharmaceutical industry. Participate in vendor audits. Assist in preparing project proposals; develop project documentation and review deliverables for technical content and overall quality as a Quality Advocate.
Individual Assignments:
Taratec Development Corporation, Bridgewater, NJ
Client: Johnson & Johnson – Raritan, PA & Horsham, PA
QA Reviewer / Sr. Validation Consultant (11/04 – 03/05)
Supporting validation & QA activities for custom-made systems like STAAR (Sample Tracking Analysis Anonymization Reporting System), SAETR (Serious Adverse Events Technical Reconciliation Application) and GREATS (Global Records and Electronic Archive Tracking System).
Responsibility includes developing Validation deliverables like Master Plan, IQ, OQ & User site testing protocols, coordinating UAT, protocol executions and generating summary reports, performing Quality Assurance Reviews on the Validation Deliverables that are being created during the validation efforts for these computer systems, which will be used by the Clinical groups, QA department, and multiple internal business practices at clients for various purposes.
Taratec Development Corporation, Bridgewater, NJ
Client: Millennium Pharmaceutical Incorporation – Cambridge, MA
QA Reviewer (07/04 – 11/04)
Retrospective validation for Computer Systems connected to the lab instruments like: Agilent UV Chemstation, Brinkmann Workcell Titration, Dionex Chromeleon System, Molecular Dynamics ImageQuant System, Thermo-Nicolet OMNIC system, Molecular Devices SOFTmax Pro system etc.
Responsibility included performing Quality Assurance Reviews on the Validation Deliverables that are being created during the remediation effort for the above computer systems, which are being used by Investigational and Commercial Quality Control groups for providing extensive data calculation and analysis capabilities under a GLP/GMP work environment for pharmaceutical and biotechnology companies.
The lower level QA review includes reviewing the entire validation package, documents including: SDLC Planning Forms, Validation Master Plan, User Requirement Specification, Functional Requirement Specification, Design Configuration Specification, Impact and Risk Assessment Report, Traceability Matrix, Data Migration Protocol, IQ/OQ/PQ Protocol, IQ/OQ/PQ Reports, Validation Summary Report, change Control Plan, Maintenance Plan and everything in-between.
As a Quality Assurance Reviewer for the team of 16-20, which includes the Business Owner, Business Quality Assurance group, Project manager, Validation analysts etc., responsibility includes guiding the team to follow the corporate Quality Standards for developing validation documents and also responsible for making the appropriate quality decisions.
Taratec Development Corporation, Bridgewater, NJ
Client: Eli Lilly - Indianapolis, IN
Quality Advocate (08/03 – 06/04)
Remediation for Analytical Data Management Integrated Network/Laboratory Information Management System ADMIN/LIMS 2.0 which includes systems like Analytical Data Management (ADM), Specification and Method Management (SMM), Lab System (LS), External Submitter (ES), Result Entry (RE) and Lot Release (LR), etc.
Work with client’s Quality Control group and SMEs to set the expectations and quality standards for developing deliverable.
As a Quality Control for the team of 20, responsibility includes guiding the team to follow Lilly Quality Standards for developing testing documents and making the right quality decisions.
Also responsible for developing Test Plan, Problem Report Tool, Requirement Traceability Matrix and Test Summary Report.
Perform requirement reviews to make sure that each requirement is appropriately tested as per the quality standards and generate Requirement Traceability Matrix mapping the system functional activities against URS, FRS requirements using -Requisite Pro- tool.
Coordinating Testing activities by managing test deliverables in document management tool - ‘Clear Case’, supporting test execution, generating Problem Report Matrix and Summarizing the test activity in the Test Summary Report.
Performing quality review on the entire validation package for each of the above systems.
Introduced reporting process for the group to manage the activity of each team member by developing Checklists and Tracking Sheets for each phase of the test case development and reviews.
Taratec Development Corporation, Bridgewater, NJ
Client: Schering Plough - Kenilworth, NJ
Quality Assurance Engineer (05/03 – 08/03)
Involved in Performing High level Compliance Assessment and Gap Analysis for Clinical Data Management Systems CDMS v2.1.1 and Clintrial v4.3 by interviewing key personnel representing Application support, Infrastructure and Database Administration; and by reviewing validation package of over last 5 years for the entire CDMS system.
Reviewed system life cycle documentation, Change Request Forms, SOPs, Infrastructure and Database Administration IQ/OQ documents, Platform Logs (Application, Infrastructure and Database Administration) and Part 11 Assessment documents.
Designed Validation Assessment Report that detailed findings and recommendations for the assessed systems to be compliant with Current Company Standards and GxP regulations.
Taratec Development Corporation, Bridgewater, NJ
Client: J&J PR&D - Raritan, NJ
Validation Specialist (01/03 – 05/03)
Developed Installation, Operational and Performance Qualification protocols and Data Migration Protocol for Clinical Trial Management System (eClinical) v1.0.
Designed Validation Strategy Document, Server IQ/OQ and System modular IQ/OQ/PQ protocol, RTM mapping the system functional activities against URS, FRS, DDS and TDS requirements, and Validation Summary Report.
Reviewed SOPs in place and created new system specific procedures.
Taratec Development Corporation, Bridgewater, NJ
Client: Aventis - Bridgewater, NJ
Validation Specialist (08/02 - 12/02)
Performed 21 CFR Part 11 Assessments of Laboratory software, instruments and Systems for Aventis.
Responsibility included confirming the system inventory for electronic records and conducting the interviews with System Owner, User or/and Quality assurance manager to fully understand the function of the assigned systems.
Analyzed SOPs in place, reviewed current validation documents, record availability, and audit trail capabilities and logical, physical access to the system.
Participated in 21 CFR Part 11 Compliance assessment meeting for Laboratory, Computerized and/or Enterprized systems like PathData v6.1, Micromass Masslinks, Xybion Path/Tox System v4.2.2, ARGUS WEB System, EM scope, E2B Export for FDA System, Microsoft Excel, PHINS v1.1, VecgLab v3.11.1, 32 Karat Software, Proventis, Reese Monitoring, DMS, GSDA, Chemstation A.08.03, Registration Database, BI Query for Ad-Hoc Query Group, Windox, Omnic Thermo Niclolet, pKalogP and DPAS, KS400, QMAN, S-Plus, ClinPro v6.0, SAS and TFR/TOX; and prepared Assessment Tool documents and Compliance Strategy Documents for long term/short term Procedural and/or Technical Solutions.
Completed assessment checklists based on the interviews and developed Compliance Assessment Reports for assigned Laboratory software, instruments or a System. Created Compliance Strategy Document detailing identified gaps and recommending technical and procedural controls to make Legacy systems compliant with current 21 CFR Part 11 regulations using Assessment Tracking Tool (ATT) i.e. Access database.
Taratec Development Corporation, Bridgewater, NJ
Client: Johnson & Johnson - Corporate HQ, East Brunswick, NJ
System Test Engineer (01/02 - 08/02)
Performed system testing and regression testing for a Oracle Clinical based data acquisition & reporting system called ‘Compliance Early Warning System’.
Lead the system testing for a requirements review, preparing test specification, test plan and test case writing, creating test data, calculating expected results, developing traceability matrix mapping the system functional activities against requirements and test case execution.
Involved in testing back-end on an Oracle/Unix-based system using SQLPLUS queries in SQL Navigator, UNIX scripts, and also testing to verify the performance of the application under heavy report generation load.
Tracked defects using SCR (System Change Request) tracking tool and Communicated with developers for existing and new defects interacted with Users and Developer for optimal solutions.
Prepared Test Summary Report and a Release memo for the system to be successfully released from Testing Instance on to Quality Instance.
Taratec Development Corporation, Bridgewater, NJ
Client: J&J PR&D, Raritan, NJ
Validation Specialist (10/01 - 12/01)
Responsibility included collecting inventory of Laboratory software, instruments and computerized systems for GLP, GCP, cGMP and electronic records compliance.
Created and maintained systems inventory under MS Access Database for efficient tracking and various reporting purposes.
Taratec Development Corporation, Bridgewater, NJ
Client: Merck Pharmaceutical Co., Rahway, NJ
Software Test Engineer (01/01 - 10/01)
Primary responsibilities included testing the VB-based custom applications (now known as Oracle Clinical) within Clinical Trial System. Clinical Trail System include the custom applications like, Collector, DBSELECT (To select specific database instance for CTS applications), DTS (Discrepancy Tracking System), DM (Data Management), AE (Auto Encoder), ME (Manual Encoder), TS (Trail Setup), EDMS (External Data Management System), DT (Data Tracking) and TDR (Trial Data Review) etc…
Also involved in testing of SMART (Support, Monitor, Analyze, Research Tool) application which was developed to correct data directly in core tables, when there is a need to solve a data related problem.
Played major role in performing co-existence testing of CTS application with Genesys application to test CTS functionality when CTS & Genesys applications co-exist on the same clinical workstations.
Developed and executed test cases, test sets, and generated reports using Test Director.
Evaluated database using the back-end testing by writing SQLPLUS queries and Shell scripts using SQL Navigator.
Analyzed test results and pinpoint the cause of failures.
Prepared the Test Summary Report and archived the test evidence and documentation in Documentum.
Taratec Development Corporation, Bridgewater, NJ
Client: Merck Pharmaceutical Co., Rahway, NJ
Validation Specialist/Quality Assurance Engineer (11/00 - 10/01)
Conduct User Acceptance Testing for CSOPS (Clinical Supplies Order Processing System) – a Web-Application that was designed to improve accuracy in the preparation of the ‘Clinical Supply Requests’ using the Electronic Media to Record, Route and Distribute ‘The Request’ to reduce cycle time from origination to fulfillment and developed using Oracle 8.1.7, Java, Java Script and Crystal Report.
The responsibilities included coordinating a team of 20-25 users, interacting with the development team, preparing testing deliverables and evidence, and quality control & coordination of the User acceptance testing.
Designed test procedures and test cases that verify system works as per user requirements.
Prepared test environment, installed application and assisted in training users for UAT.
Prepared the Test Summary Report and release memo after successful completion of User Acceptance Testing.
Archived and maintained test evidence and other supporting testing documentation in Document Management System.
Taratec Development Corp., Bridgewater, NJ
Software Test Engineer (10/00 - 11/00)
Responsibilities, included test scripts development, review, and execution for System & Regression testing of the multiple version of Java based ‘Internet file system’ application.
Wrote Test Plan, Designed, reviewed and executed test Cases.
Developed defect-tracking system to track and manage defects found during test case execution. Interacted with developer to Co-ordinate fixes.
Taurus Technology Inc., NJ
Software Quality Assurance Tester (05/00 – 10/00)
Responsibilities:
Perform software quality assurance testing to validate the product to assure the high quality standards by performing manual testing. Participate in team meetings, manage individual tasks and submit status reports on regular bases.
Individual Assignment:
Taurus Technology Inc., NJ
Software QA Tester (05/00 - 10/00)
Primary responsibility of validating the product to meet the high quality standards by manual testing of Recruiting Management client/server application in an UNIX environment.
Reviewed software life-cycle requirement documents and test plan walk-through to provide/receive feedback.
Wrote test plan and tests cases specification document from requirement.
Responsible for developing test tools and execute and maintain test cases in test-result document by tracking all test status and problems found and also worked with developers to drive the problem closure.
Testing included functions testing, negative testing, acceptance testing, regression testing, GUI testing and End-to-End functional testing.
Perform query operation on Oracle database for validation. Use SQL Plus to do database queries and enter/update more data in the Oracle database.
Report defects/Modifications to developers through MKS tracking tool.
Retest the modifications, once bugs are fixed after reinstalling the application.
Apex Electricals LTD., Baroda, INDIA
Software Tester (08/96 - 06/98)
Responsibilities:
Perform software testing to validate the product to assure the high quality standards by performing manual testing. Analyze requirements, develop manual test scripts, execute scripts in the testing environment and submit performance report to QA manager. Train and support users during UAT.
Individual Assignment:
Apex Electricals LTD., Baroda, INDIA
System Tester (08/96 - 06/98)
Involved in system testing of Material Management system under IBM mainframe system, which was coded in C/C++ using ORACLE 7.3 Db under UNIX environment.
Analyzed the user requirements and system requirement documents to write test plan and test cases.
Executed test cases to test various functionality of software application. To execute test cases prepared test environment and test data.
Responsibilities included developing of Milestones and Detailed Cycle Schedule.
Generated matrix reports to evaluate the performance of the application and also Responsible for reporting the upper management.
Trained the Users in different application usage.
Provided support to Users by investigating the TRs (Trouble Reports) and offered them solutions.
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