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Validation Lead Resume

OBJECTIVE:

Seeking a highly motivated and progressive environment which provides challenging assignments where my abilities can be effectively utilized allowing me to grow in skills and position.

SUMMARY:

  • Requirement analysis, test data preparation, test case execution, bug logging and reporting.
  • Computer System Validation / 21 CFR Part 11 and Root Cause Analysis (RCA) on process deviations/Quality issues
  • Ensuring all activities related to applicable computer systems are in compliance with cGXPs
  • QA review and approval of validation artifacts for computerized system implementations
  • Regression test, Sanity test and UAT support.
  • Database validation with SQL.
  • Preparing and reviewing test cases and requirements.
  • Preparing traceability Matrix for functional completeness.
  • Functionality, compatibility, reliability, usability, smoke, adhoc, installation, security and related test methodologies. Testing of web application, client - server, network and database projects on Windows and Linux environments. Knowledge of SDLC, STLC and well acquainted with all the stages.
  • Leadership roles in creation and execution of QA and testing processes, test strategies and plans, bug documentation and regression
  • Analysis of requirements, enhancements and modifications.
  • Preparing functional specifications.
  • SPOC at offshore for the functional queries and concerns.
  • Liaising with domain experts, business users, onshore team and senior product owners for business process comprehensiveness and issue resolution activities
  • Effective coordination with onshore development and testing team and clients.
  • Experience in Business Requirements Analysis to orchestrate new enhancements and business logic.

TECHNICAL SKILLS:

Operating System: Windows98, 2000, XP, Vista, Linux, Oracle SQL

Test Management Tools: Quality Centre, Clear Quest, ERS-Jira, Bugzilla, CCL.

Configuration management tools: Subversion, Clearcase, Citrix, VSS, PVCS

Network monitoring tools: Wireshark, Comnet

Automated testing tools: STATE, Working knowledge of QTP and VBScripting, QALoad

EXPERIENCE SUMMARY:

Confidential

Validation Lead

Responsibilities:

  • Leading and planning the validation activities
  • Functional Risk Assessment and Criticality Analysis for requirements
  • Project schedule & tracking, coordinating the validation tasks
  • Mentoring new team members.
  • System configuration and validating the configuration changes.
  • Reviewing and updating the master qualification deliverables.
  • Assuring that the system meets its requirements and compliance with SOPs, applicable client policies and procedures, and the requirements of Validation Plan.
  • Risk based validation testing, reviewing and approving test executions.
  • Reviewing the UFRS to suggest scope changes.
  • Authoring and executing OQ/PQ Scripts for Argus Safety 7.0.2
  • Creating and maintaining Traceability Matrix

Confidential

Senior Consultant-Validation

Responsibilities:

  • Assuring that the system meets its requirements and compliance with SOPs, applicable client policies and procedures, and the requirements of Validation Plan.
  • Reviewing the UFRS to suggest scope changes.
  • Reviewing the existing workflow and access setup and suggest changes.
  • Authoring and executing OQ/PQ Scripts for Argus Safety 6.0.6
  • Authoring and executing Performance Scripts for Argus Safety 6.0.6
  • Creating and maintaining Traceability Matrix

Confidential

Validation Lead

Responsibilities:

  • Analysis of user requirements.
  • Validation Planning
  • Creation of Operational Qualification (OQ) scripts and validation SQL queries.
  • Creation of Requirement Traceability Matrix.
  • Dry run and Final Execution of OQ scripts, Defect reporting and retesting.
  • Leading the validation team though the testing cycle.

Senior Consultant-Validation

Confidential

Responsibilities:

  • Analysis of user requirements.
  • Creation of Operational Qualification (OQ) scripts and validation SQL queries.
  • Creation of Requirement Traceability Matrix.

Confidential

BA

Responsibilities:

  • Assuring that the system meets its requirements and compliance with SOPs, applicable client policies and procedures, and the requirements of Validation Plan.
  • Preparing and reviewing test cases and requirements Traceability Matrix for functional completeness.
  • Test data preparation, test case execution, bug logging and reporting
  • Regression test, Sanity test and UAT support
  • Database validation.
  • Load testing using QALoad.
  • Led a team of 6(including onshore and offshore resources) for Oracle Application and database upgrade from 10g to 11g.
  • Liaison with Domain experts, business users, onshore team and senior product owners business process comprehensiveness and issue resolution activities.
  • Prepare Test Cases & Execution of Test Cases.
  • Performed Functional, Regression and System Testing of the application.
  • Liaison with Domain experts, business users, onshore team and senior product owners business process comprehensiveness and issue resolution activities.
  • Interface testing and UAT support.

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