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RAJENDRA PRASAD. A

Email: adymrs@r.postjobfree.com

Phone: 469-***-****

Professional Summary

* **** ***** ** ********** in Quality Assurance and testing of web-based and client-server applications with effec- tive use of Software Testing Methodologies.

10 plus of experience in Quality Assurance (Computerized System Validation) IT in Pharma domain.

Proficient in Software Testing life cycle (STLC), Agile Methodology and Manual Testing.

Vast experience in Functional testing, GUI testing, and Regression testing on variety of applications.

Experience in different types of testing - Smoke, Functional, Regression, Adhoc, Sanity, Integration Testing, Cross Browser & OS, Browser Compatibility, Exploratory and knowledge in Non-Functional Testing.

Proficient at defect tracking tools like Jira and ALM.

Proficient in writing test cases, executing test cases and analysing the defects.

Knowledge in Postman to execute Web Services Testing (API).

Collaborated with teams during both Agile and Waterfall model implementations.

Extensive experience in collaborating with cross Functional teams and Customers to capture test require- ments, analyse them and provide required test plans.

Exposure to regulatory audits (USFDA and EU audits).

Handled analytical instruments like HPLC, UPLC, GC by using CDS like Empower & & Chromeleon, UV & IR.

Reviewed and approved various analytical instruments and Engineering equipment qualifica- tion protocols (URS, FRS, DQ, IQ, OQ & PQ).

Verifying and validating the software as per 21 CFR 11, GAMP and EU guidelines.

Reviewed various QMS elements as per FDA regulations. Skills Summary

Operating Systems Windows, Unix(Linux )

Databases Oracle, MS SQL Server, DB2

Testing

methodologies

Manual, Functional, UI, Regression,Compatibility, Sanity and Database testing using SQL

Programming

Languages

SQL

Professional Experience

Client : AbbVie (Feb 2020 to Jan 2023)

Role : Quality Engineer

Project Description:

AbbVie pharmaceuticals combines advanced science with expertise to make strides in drug and treatment discov- ery, making a remarkable impact on peoples.

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AbbVie pharmaceuticals drives innovation and impact in health care through a focus on research, biopharmaceuti- cal manufacturing and industry leadership.

Roles and Responsibilities:

• Preparing Test Scenarios and Test Cases from Acceptance Criteria.

• Identifying the Test Cases to be automated

• Creating test scripts.

• Executing test scripts.

• Analyzing test results.

• Preparing test data, test case execution, and pass/fail reports generation.

• Functional Testing, Integration Testing, Regression Testing, System Testing.

• Logging defects in ALM

• Creating Agile Metrics sheet at the end of Sprint Client: LEONS

Project Name: The HORIZON BCBS OF NEW JERSEY (April 2017-Feb 2020) Role: Test Engineer

Project Description:

Horizon Blue Cross Blue Shield of New Jersey is a health insurance company based in the United States providing health insurance coverage. This project aimed to have a single view of a patient history including his medical ail- ments and diagnosis. The project involves data flow from Oracle to multiple layers. Roles and Responsibilities:

• Involved in preparation of Test plan.

• Preparation of test cases based on Functional specs and business requirement documents.

• Reviewing test cases and suggesting modifications through review report.

• Performed System Testing.

• Executing the Test cases and reporting the bugs through ALM.

• Involved in defect review meetings with Onshore Team.

• Daily updating the Test case execution status.

• Hands on UI Testing

• Raising Defects and following the defect life cycle process.

• Requirement analysis and tracking the clarifications from Clients.

• Application and domain knowledge transition to the new joiners in the project.

• Coordinating the offshore team and ensure the quality of the deliverables.

• Facilitating Defect Calls with Development team and business partners.

• Perform Functional, Integration and Regression testing.

• Generating reports based on the Test case runs and presenting to business teams. Page 3 of 3

Client: Dr. Reddy’s (July 2009-March 2017)

Role: Quality Assurance -IT compliance

Job Description: Computerized system validation

• Involving the new systems software validation and validating the legacy & new instruments software by following the GAMP (V-model), EU and 21 CFR-11 guide lines.

• Qualifying the instruments software as part of UAT.

• Designing the functional specification requirements as per user needs and testing the customised applications which are developed by in-house team.

• Testing the positive and negative testing during qualification of instruments as part of UAT.

• Prepare the test cases and test reports.

• Reviewed and approved of software instruments of related URS, DQ, IQ, OQ, PQ qualification and risk assessment documents at site and approved the vendor qualification documents.

• Handled analytical instruments like HPLC, UPLC and GC with Empower software, UV and IR instru- ments

• Reviewed and approved various Engineering equipment’s documents like URS/FRS/IQ/OQ/PQ proto- cols and reports.

• Exposure to regulatory audits (USFDA and EU audits). Client: Hetero Drugs Ltd. (Nov 2006-June 2009)

Role: IT Engineer-QA

Job Description: Computerized system validation

Performing the legacy instruments software (analytical & production) related gap analysis and resolving the identi- fied gaps. Software validation for new instruments during qualification of instruments. Verifying the software as per 21 CFR-11, GAMP & EU guide lines.

Educational Qualification

• Master of Science from Bangalore University, India.

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