PROFESSIONAL SUMMARY:

• 6 years of experience in Quality assurance with strong background in computer system validation, Software Development Life Cycle (SDLC), technical writing along with performing manual and automated testing.
• Experience in computer system validation (CSV), equipment Validation, technical writing and testing with strict adherence to GAMP & cGMP regulations.
• Expertise in technical writing including guides, validation master plan, test cases, test summary report, business continuity plan (BCP), disaster recovery plan, CAPA, technical impact assessment (TIA), SOPs required for software validation.
• Exceptionally organized, detail - oriented and outcome-focused analytical chemist, with hands-on experience in HPLC and GC, UV-Visible Spectrophotometer (double beam) dissolution & disintegration apparatus.
• Coupled with well-honed expertise in mass spectrometry analysis, comparative effectiveness methodologies, curriculum/program design, and research and development.
• Interested in pursuing a challenging yet rewarding career to leverage extensive research, critical thinking, and communication skills within the pharmaceutical industry and the government sector as well as to utilize knowledge and abilities in a variety of scientific and research functions.
• Reviewed study data for quality assurance; participate in various activities, communicate with management with respect to study related issues.
• Ability to work effectively independently and in an interdependent, team-oriented environment on a consistent basis.
• Equipped with outstanding organizational and analytical skills in evaluating and revising scientific research processes as well as in improving accuracy and efficiency.
• Quick-thinker and effective problem solver, with the ability to synthesize diverse and complicated information to produce rapid solutions.
• Highly adaptable and trainable; able to quickly learn and apply complex technical concepts.
• Articulate public speaker and writer; expert in presenting complex ideas clearly and concisely
• Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), Origin Graphing Software, Data Analysis.
• Hands - on experience with HPLC model ‘Analytical Technologies’ manual injector system with A2000 Software.
• Experience in handling of UV-Visible Spectrophotometer (double beam) model PG ‘Instruments’ with UV-Win software in the method development and validation of pharmaceuticals.
• Experience in handling of Dissolution (manual) & Disintegration apparatus, Nephloturbidometer, Karl Fisher titrator & various other laboratory instruments.
• Acquired good practical knowledge in calibration of HPLC system, UV-Visible Spectrophotometer & pH meter.

KEY SKILLS:

• Ability to work as a team player as well as an individual with excellent communication skills
• Result oriented and possess high degree of Professionalism
• Good Analytical and Technical Skills
• Scientific Expertise in UV spectrophotometer(Systronics), FTIR spectrophotometer (Perkin Elmer), Dissolution apparatus (Electrolab), Micropipette (Tarson), Centrifuge (Remi), HPLC (Perkin Elmer)
• Well acquainted with softwares such as Design Expert, PCP Dissolution and GraphPad

COMPUTER SKILLS:

Proficient in: Microsoft Windows 98, 2000, XP, 2007, Microsoft Office Suite (Word, Excel, PowerPoint and Access).

Scientific Information: Retrieval using search engines like Science Direct, Pubmed, Scirus, Informa Healthcare, Google Scholar.

Languages: C, PL/SQL, UNIX Shell Scripting

Databases: Oracle 10g/9i/8i, Oracle Clinical 4.x, MS Access, SQL Server 2000, DB2, Teradata.

Applications: MS Office - Access, Excel, Power Point, & Word, Photoshop

Operating Systems: MS-DOS, Windows 9x/NT/2000/XP, UNIX, Linux

WORK EXPERIENCE:

Validation Test Analyst

Confidential, Waukegan, IL

Responsibilities:

• Gathered and analyzed business requirements, translated business requirements into system requirements
• Managed high profile project work streams for the agency through iterative methodologies such as WATERFALL; managed project features, tasks and improvements through SCRUMS
• Waterfall methodology to execute complete Software Development Lifecycle (SDLC) solutions, including requirements gathering, test planning and execution, design.
• Developed Validation Test Plan in conjunction with FDA regulations
• Assured that all validation documentation such as IQs, OQs and PQs are in compliant with cGMPs (21 CFR Part 210/211)
• Developed documentation for all aspects of the Computer System Validation Lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11, including: Validation Plan and Protocol, Installation Qualification (IQ), Operational Qualification (OQ)
• Prepared routine reports on the progress of assigned tasks
• Developed Test Cases to Perform complete manual testing of the application
• Base line the test plan, test criteria & Project Schedule by walkthroughs and reported the defects using HPALM. Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are created by the application and constantly redesigned the system to increase its user friendliness for the clients
• Performed GAP Analysis and also developed the corresponding Remediation plan
• Authored various Validation Deliverables like Test Plan, Test Summary report and Final Validation Report maintaining company standards

Test Analyst

Confidential, Detroit, MI

Responsibilities:

• Worked on Test Planning - Requirement analysis and Test cases creation, Test Data Management-Prepared test data by data mining, Test Execution- Run test cases in Rational Quality Management (RQM) and defect management - Logging defects and reporting with clear quest.
• Identified, built and executed Test Cases and Test Sets for Functional, Error Handling, Navigation and Regression testing.
• Developed test plans, test scenarios, test cases and manual test scripts for complex and highly integrated enterprise systems, products and applications.
• Performed Data Driven Tests to validate the same scenario with different test data using Toad.
• Performed validation across database and application with queried result is being equal, SQL queries is being extensively used to check the data from the database using Toad.
• Wrote and execute SQL queries to validate or gather test data.
• Extensively focused working on & 835 end - end testing & involved in all the E2E testing activities.
• Test Data preparation for both Institutional and Professional 837 Claims.
• Ensured content & structure of all the test artifacts is documented & maintained.
• Prepared status summary reports with details of executed, passed and failed the status to business partners and leadership.
• Involved in HIPAA/EDI Medical Claims Analysis, Design, Implementation and Documentation.
• Validated the reports and files according to HIPAA X12 enforced standards.
• Monitored testing activity and conduct test result reviews.
• Published all functional and specification documents in Share point.
• Define critical areas of what to test during system testing and perform risk assessment.
• Report System integration testing status to management on test execution/defects to the QA lead/Manager on daily basis.
• Manage the entry and exit of projects into and out of System Integration test(SIT) and User Acceptance Testing(UAT)
• Establish good working relationship with internal and External Teams.
• Worked with team to identify continuous improvement.

Environment: Rational Quality Manager(RQM), Clear Quest, DB2, JCL, File aid/Ultra Edit, SQL,TSO,ISPF, MS excel, MS Word, MS PowerPoint, SPUFI, FTP, MS Office, Visio, Toad -SQL, Oracle DB

Test Analyst

Confidential, Waukegan, IL

Responsibilities:

• Gathered and analyzed business requirements, translated business requirements into system requirements
• Managed high profile project work streams for the agency through iterative methodologies such as WATERFALL; managed project features, tasks and improvements through SCRUMS
• Waterfall methodology to execute complete Software Development Lifecycle (SDLC) solutions, including requirements gathering, test planning and execution, design.
• Developed Validation Test Plan in conjunction with FDA regulations
• Assured that all validation documentation such as IQs, OQs and PQs are in compliance with cGMPs (21 CFR Part 210/211)
• Developed documentation for all aspects of the Computer System Validation Lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11, including: Validation Plan and Protocol, Installation Qualification (IQ), Operational Qualification (OQ)
• Prepared routine reports on the progress of assigned tasks
• Developed Test Cases to Perform complete manual testing of the application
• Base line the test plan, test criteria & Project Schedule by walkthroughs and reported the defects using HPALM. Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are created by the application and constantly redesigned the system to increase its user friendliness for the clients
• Performed GAP Analysis and also developed the corresponding Remediation plan
• Authored various Validation Deliverables like Test Plan, Test Summary report and Final Validation Report maintaining company standards

Confidential

Responsibilities:

• Stability and Degradation Kinetics of Metaxalone and Diclofenac Potassium in Combined Form by RP- HPLC method for simultaneous determination of selected class of drugs.
• Development of a selective and sensitive analytical method for the quantitative estimations of drugs in forced degradation samples and determination of their degradation kinetics. Provides a high level of product expertise and customer service to all accounts
• Tracks activities and submits reports on sales activities accurately & on-time
• Develop and maintain strong in-depth clinical, technical and scientific knowledge.
• Worked on different Phases of clinical trials and was involved with creating, testing and maintaining programs for clinical studies.
• Performing data extraction from various repositories and pre-process data when applicable.
• Generating the demographic tables, adverse events and serious adverse events reports

Skills: Microsoft Office -MS Word, PowerPoint, Excel.