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Test/validation Lead Resume

EXECUTIVE SUMMARY:

  • Overall 17 years of QA experience, with focus on Software Development Life cycle (SDLC), Risk Assessments, and validation practices.
  • Sound knowledge of required process and controls to comply with U.S. GMPs (FDA regulations 21 CFR Part 11 regulations) and industry recognized standards such as GAMP5
  • Significant experience working in challenging environments, skilled in project management and the ability to work in a cross - functional environment effectively
  • Working experience as Validation lead in COTS, Confidential CRM & Digital Asset Library applications.
  • Proficient in performing testing of GxP & Non-GxP applications (i.e., System Integration & User Acceptance Testing in HP ALM tool and JIRA) in Waterfall & Agile methodology.
  • Experience in writing validation protocols and master plans, performing risk assessments and CAPA documentation for any deviations as required.
  • Experience in authoring and reviewing Qualification documents (IQ, OQ & PQ), Standard Operating Procedures (SOPs), Work Instructions to be compliant as per FDA Regulations
  • Extensive experience working as a Validation Lead for FDA regulated, mission critical GxP IT Systems in the Global Solution delivery model (Offshore- Onshore).
  • Strong experience in implementation of Change request through Changement Management and Release Management tool like PROMISE.
  • Over seven plus years of Project Management experience, dedicated to project excellence, delivering quality projects on time, within budget and meeting project objectives and client expectations. Experienced in Risk and Change Management & People/Team Management including managing Onsite/offshore coordination, resource handling.
  • Experienced in providing to the IT, business staff and external clients on the Quality process as Change Management, Problem Management, Software Development Life Cycle (SDLC), and Risk Management.
  • Proficient in performing GAP analysis, requirement analysis, preparation of Project Plan (MPP), Test plans.
  • Strong Software Management, Quality Assurance,, Testing and Validation experience in Pharmaceutical/CMMI companies.
  • Knowledge of Project Management Office/Test Management Office, acted as a liaison between the development team/Business users & the testing/validation team, providing support to business users in terms of Quality Centre & ensuring smooth project execution.
  • Highly motivated, quick learner, detail oriented, has ability to work independently and as a part of the team with Excellent Management, Analytical, Organizational, Communication and Presentation skills.
  • Successfully managed complex projects with global implementation, and rapidly evolving requirements.
  • Hands-on experience leading and managing concurrent projects varying in scope, schedule, and complexity. Project leadership experience successfully expands all organizational functions, and multiple industries.
  • Managed (full-time) staffs in accordance with company policies and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisals, addressing employee relations issues, and managing cost center budget.
  • Effective communication skills and record for coordination between globally located teams.
  • Conducted budget planning of the project through walkthroughs and meetings involving all stakeholders & leads from Development, QA and Technical Support teams.
  • Define Business Process; identify the risk, doing risk analysis and providing baseline acceptance criteria and deliverables.
  • Excellent verbal and written skills, especially with regards to presenting findings to both technical and non-technical audiences
  • Managing reports, analysis and decision-making for a change request.
  • Project Management, Project Schedule, Project Tracking and Team Management
  • Extensive experience in translating Business requirements to understandable IT systems requirements.

TECHNICAL SKILLS:

  • S/W development life cycle methodologies.
  • Requirements definition, functional specifications and gap analysis.
  • System Testing, end to end testing, Regression suite development and User acceptance testing.
  • Validation Plan, Functional Risk Assessment, Test Strategy, Test Protocols, Validation Summary Report, User Acceptance Report
  • C, C++
  • JavaScript, VBScript
  • Oracle, SQL Server.
  • Windows, Unix.
  • HP Quality Center, HP Application Lifecycle Management(ALM), JIRA
  • Microsoft Project
  • Visual Source Safe, Subversion, Sharepoint
  • Cognos Reports

PROFESSIONAL EXPERIENCE:

Confidential

Test/Validation Lead

Responsibilities:

  • Test Scenario review for System Integration /User Acceptance testing/End to End testing.
  • Coordinating dry runs for System integration /User Acceptance testing/End to End testing.
  • Review of testcases for System integration /End to End testing. Handling Test Data setup.
  • Responsible for updating & reviewing all project documentation pertaining to the System Integration & User acceptance testing but not limited to Test Protocol, Testcases, Test Summary Report, IQ’s & Requirement Traceability Matrix.
  • Defect management & Weekly Status reporting to all Key Stakeholders.
  • Working closely with Confidential ’s quality & compliance system validation team for document review and approvals
  • Providing process guidance to the testing team.

Confidential

Validation Lead

Responsibilities:

  • Review testcases for System Integration & User Acceptance testing.
  • Coordinating dry runs for System integration & User Acceptance Testing.
  • Responsible for updating & reviewing all project documentation pertaining to the System Integration & User acceptance testing but not limited to Test Protocol, Testcases, Test Summary Report, IQ’s & Requirement Traceability Matrix.
  • Defect management
  • Provide Validation and Compliance guidance to the project team.
  • Working closely with Confidential & Confidential ’s quality & compliance system validation team
  • Weekly Status reporting to all Key Stakeholders.

Confidential

Test Manager

Responsibilities:

  • Reviewed testcases for System Integration & User Acceptance testing.
  • Coordinated dry run with business SMEs.
  • Coordinated System integration & User acceptance test execution.
  • Updated & reviewed all project documentation pertaining to the User acceptance testing but not limited to User Acceptance Test Protocol, Testcases, Test Summary Report & Requirement Traceability Matrix.
  • Defect management
  • Provided guidance to the team on good documentation practices & process setup.
  • Worked closely with Confidential & Confidential ’s quality & compliance system validation team
  • Prepared weekly status reporting to all Key Stakeholders.

Confidential

Validation Lead/Test Manager

Responsibilities:

  • Initiated the change & release management process for any new enhancements related to existing CRM System ( Confidential ).
  • Tracked & monitored the change & release management process from initiation till closure including system integration & User Acceptance testing activities
  • Performed Impact Assessment of the enhancement.
  • Updated & reviewed all project documentation pertaining to the enhancement but not limited to Functional Risk Assessment, User requirement specification, system design specification, testcases, IP/IQ, Requirement Traceability Matrix.
  • Gathered requirement from Business SME’s & authoring user requirement specification.
  • Reviewed IQ/OQ documents.
  • Created & reviewed testing documents for system integration & User acceptance testing.
  • Coordinated System integration & User acceptance test execution.
  • Performed defect management
  • Provided guidance to the team on good documentation practices & process setup.
  • Worked closely with Sanofi’s quality team
  • Created Monthly Status reports for all Key Stakeholders.

Confidential

Validation Lead/Test Manager/Business Analyst

Responsibilities:

  • Initiated the change & release management process for new enhancements related to existing CRM System (Siebel) & Content Management Platform (Documentum).
  • Tracked & monitored the change & release management process from initiation till closure including system integration & User Acceptance testing activities
  • Performed Impact Assessment of the enhancement.
  • Updated & reviewed all project documentation pertaining to the enhancement but not limited to Functional Risk Assessment, User requirement specification, system design specification, testcases, IP/IQ, Requirement Traceability Matrix.
  • Gathered requirement from Business SME’s & authoring user requirement specification.
  • Reviewed IQ/OQ documents.
  • Authored & reviewed testing documents for system integration & User acceptance testing.
  • Coordinated System Integration & User Acceptance test execution
  • Performed Defect Management
  • Provided guidance to the team on good documentation practices & process setup.
  • Worked closely with Sanofi’s quality team
  • Created Monthly Status reports for all Key Stakeholders.

Confidential

Transition Manager/UAT coordinator

Responsibilities:

  • Led & supported the knowledge transition effort by creating transition plan for the below applications. iStore-New CTM warehouse system to retrieve clinical trial data from the legacy CTMS inside the common shared CTM HUB iReport-Reporting Solution for Trial Management to deliver clinical trials monitoring and performance reports iCONDUCT-New CTMS system replacing the legacy CTM systems.
  • Tracked & monitored the transition activities between the project team & support team.
  • Followed up with different Solution leads on regular basis regarding the availability of required documentation for seamless transition.
  • Set up meetings with different solution leads/project team to plan the transition timelines. And ensured resource availability for transition.
  • Managed UAT Script Development activities
  • Setup HP ALM for newly onboarded users with ALM coordinator
  • Initiated & coordinated with business users for Regression Test execution, UAT execution on validated environment.
  • Consolidated Regression Test issues and initiated discussion with product vendor
  • Worked closely with Validation Lead to review & update quality documentation
  • Created Weekly Status reports for all Key Stakeholders.
  • Conducted knowledge transition meetings with support team to gain better understanding of Legacy CTMS systems.

Confidential

Validation Lead/Test Manager

Responsibilities:

  • Supported the validation effort by developing and reviewing validation deliverables.
  • Provided consultation as appropriate during the project.
  • Created validation documents following Confidential specific validation guidelines (PUMA methodology)-
  • Coordinated with Confidential Business User, development team & other vendor for the smooth execution of the project.
  • Provided support in the defect management process i.e., creation of anomaly forms for system errors or Good Documentation Practice issue.
  • Provided analysis of anomalies & recommendations.
  • Participated & coordinated status meetings.
  • Trained/Mentored Junior Validation Engineers
  • Took initiatives focusing on value addition to the organization and customer

Confidential

Project Manager/Test Manager

Responsibilities:

  • Participated as a key team member in Project /Test Planning.
  • Assigned daily task to team members
  • Conducted weekly team meetings
  • Handled people/resource management
  • Provided monthly forecast to senior leadership.
  • Participated actively for the development of migration test plan, assisted migration development team to implement QA processes and to bring migration specification documents to completeness following validation guidelines.
  • Conducted test design, dry run and system testing (OQ).
  • Coordinated with Application team, Migration team for change management requests and did the frequent impact assessment. Performed gap analysis and kept client and partners aware of all possible Risk and issues.
  • Handled resource planning, estimations & monthly billing forecast.
  • Coordinated with Installation/Configuration team for environment setup and readiness.
  • Coordinated with project QR to implement all GxP/non-GxP guidelines in all phases of Testing life cycle.
  • Prepared/maintained Requirement Traceability Matrix per functional area, prepared summary memo as part of Validation summary report.
  • Created Test and Defect Summary reports
  • Maintained Project Documentation
  • Conducted Defect Management and Status Reporting
  • Take initiatives focusing on value addition to the organization and customer

Confidential

Test Manager

Responsibilities:

  • Handled Resources, Timelines, Validation and all Project Documentation.
  • Engaged in Leadership activities including development, coaching and day to day management.
  • Ensured availability of resources and programs to develop technical and other skills, to complete their jobs.
  • Ensured standardization of processes & tools across shared services.
  • Ensured 100% requirement coverage using Quality Center tool.
  • Managed staffing, billing, metrics reporting, status reporting, issues/concerns.
  • Handled Offshore and Onsite Management.
  • Authored & reviewed validation documentation.
  • Evaluated processes and make recommendations for change and growth.
  • Performed scheduling, tracking, reporting and achieving Project deadlines in conjunction with the Project Management Office (PMO).
  • Responsible for /Mentoring Junior Validation Engineers.
  • Work with system/process owners in harmonizing the process areas.
  • Lead a team to develop Processes and write Global Standard Operating Procedures (SOPs).

Confidential

Project lead/Test Lead

Responsibilities:

  • Worked as a Data TMO for Group 3A execution.
  • Supported business users/SME in terms of Quality Centre navigation, maintaining centralized L1/L2 approver's list & TIR (Test Incident Report) generation.
  • Acted as a liaison between the Global Data Leads/development team/Business users & the testing team during the data migration phase of SIT (System Integration Testing) & AT (Acceptance Testing) & ensuring smooth execution in each phase.
  • Ensured Confidential SLDC/process being followed by both the development & testing team.

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