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

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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