Lead Software Test Engineer Resume

SUMMARY:

Over 10 years of experience in Software Validation, Testing, and extensive knowledge in Software Development Lifecycle Management.
Extensive knowledge in Computer System Validation, Periodic Reviews; both Internal and External Audits.
Thorough knowledge of gap analysis and CAPA processes.
Expert in Software Quality Assurance methodologies.
Experienced in Quality/Regulated environments and implementation of Quality Systems for software adhering to FDA standards.
Qualified in implementing quality systems in line with SDLC requirements and developing Validation Risk Assessment Plan/Summary Reports.
Responsible for adhering to 21 CFR Part 11 - Electronic Record and Electronic Signature requirements, Security, Audit trail (user and date time stamps) standards during testing phase.
Actively participated and coordinated development of SOP’s, validation plans, and training documents.
Coordinated guideline specifications, design specifications and writing test summary, traceability matrix, testing incident report and risk assessment documents.
Excellent experience in Database Testing, Ad-hoc testing, Security Testing, Agile testing and System Testing.
Led over 100+ in-house projects as a lead tester, managing a team of over 10 testers globally located.
Wide experience in writing test plans/test cases for IVRS (Interactive Voice Response Systems), IWRS (Interactive Web Response System) and IMRS (Interactive Mobile Response Systems).
Experienced in leading both onshore and offshore in a fast-paced agile environment.
Provided product training and mentoring for new recruits.

TECHNICAL SKILLS:

Operating System: Windows and UNIX.

Languages: SQL, HTML, CSS, XML, Java Script, VB, .NET, and ASP applications.

Databases: Oracle, Microsoft SQL Server, MS Access, and AQT.

Software Packages: MS Office and Internet Services (MSIE, Mozilla, Microsoft Expression, IE Tester).

Tools: QTP, Selenium, Seapine, Quality Center, Spirateam, Bugzilla, SharePoint and JIRA.

Hardware: MAC and Windows.

Others: GDP, HIPAA, MEDICAL CODING, 21 CFR Part 11 and CERNER.

PROFESSIONAL EXPERIENCE:

Lead Software Test Engineer

Confidential

Roles & responsibilities:

Involved in on-going process improvement and uplifting quality management.
Provide and mentor project team with testing progress and continuous risk assessment during testing phases.
Lead testing team and act as the main point of contact/escalation.
Led both an onshore and offshore testing teams.
Responsible for approving and acknowledging trial/study related documents.
Involved in investigation any IR’s reported by clients. Developed root-cause analysis documents for CAPA for internal analysis.
Conducted post mortem analysis and process improvements to proactively introduce new methodologies for reducing production incidents.

Senior Software Test Engineer

Confidential, Langhorne, PA

Roles & responsibilities:

Lead teams in testing efforts on various projects.
Work closely with Technical Delivery/Product Development teams to formulate high level testing solution and responsible for ensuring that the testing strategy includes complete coverage of requirements and business process.
Develop test cases for IVRS, IWRS and IMRS.
Executed test cases in Selenium and used Python for modifying scripts for automation testing.
Wide experience in testing ALMAC, Fisher, Medidata, PRA, and PMD integrations.

Validation Analyst

Confidential, Totowa, NJ

Roles & responsibilities:

Worked as a validation consultant for Confidential an inventiv company, testing their warehouse ARTHUR in their supply chain management system.
Confidential uses COTS product Integrated Logistics System (ILS) to manage their various warehouse’s in U.S.A.
Developed test plans and test cases for Arthur warehouse which includes testing of configurations, receiving, work order processing and shipment of various OTC, controlled drugs, non-controlled drugs and refrigerated drug products.

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