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.