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Quality Project

San Mateo, CA
May 16, 2020

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Experience Summary:

●Over ** years of IT experience with expertise in Computer System Validation (CSV), Business Analysis and Software Testing.

●Expertise in defining and executing validation strategy to ensure that validation documentation is complaint with GMP standards, policies, guidelines and procedures.

●Expertise in validating Veeva Vault- Document Management Systems (GVault), Integrated Quality System (IQS), Product Lifecycle Management (PLM), Identity Management System (IDM), Oracle ERP-EBS application used in the drug discovery, development and manufacturing domains.

●Extensive experience in preparing URS, FRS, Report Specification, Validation Summary report, Installation Qualification (IQ),Operational Qualification (OQ) and Performance Qualification (PQ).

●Knowledge of the GMP, GLP and GDP.

●Extensive experience in creating Change Management request, Deviation and CAPA in electronic reporting systems (TrackWise) and using root cause analysis tools for identifying and correcting deviations.

●Experience in FDA regulated environment with expertise in implementing 21CFR part 11 compliance requirements.

●Expertise across all phases of Software Development Lifecycle (SDLC) in a FDA regulated environment.

●Expertise in developing and maintaining UAT scripts, Test Summary Report, RTM and operating and maintaining Standard Operating Procedures (SOPs)/Training Materials/User Guides.

●Extensive experience in working with multiple cross-functional & technical teams for complex projects.

●Hands-on experience in HP-Quality Center Test management tool at Advance (admin) level.

●Detail-oriented professional with excellent analytical, problem-solving, communication and interpersonal skills, leadership and team building qualities.

●Ability to multi-task and work independently, as well as collaboratively with geographically co-located or distributed multiple project / business teams.

Technical Skills:

Testing Tools:

HP-ALM (Quality Center) 12.x, HP-FT (QTP), Selenium, VersionOne


Web (Java, .Net) & Client/Server Applications, OBIEE, MS SharePoint, IBM IFW & M1, MS-Visio.


Basic knowledge of Object Oriented Analysis, Design & Programming methodology. Core Java, C.


Oracle SQL Developer, Relational data modeling, SQL queries. AS400, (Hub Import Export – HIE, Hub Front End – HFE).


Agile PLM, Veeva Vault QualityDocs, SailPoint-Identity Management solution (IDM).

Operating System:

Windows NT/2000/XP,Windows7, Windows10

Business Domains:

Life Sciences; Banking and Financial Services

Academic Qualifications:





Data System Research Foundation, Pune University

MCM (Master’s Degree in Computer Management)


St. Mira’s Girls College Pune, Pune University

B. Com (Bachelor Degree in Commerce - Banking & Costing)

Professional Experience:

Business System Consultant Feb 2016 – Feb 2020

Gilead Life Sciences, USA (PDM – LIS)

GPLM Project

●Completed my assignment for GPLM (Product Lifecycle Management) project as Data Steward.

●Participated in Conference Room Pilots (CRP) for gathering requirements and analysis.

●Prepared user requirement specification for GxP and Non-GxP system.

●Developed traceability between Use Cases to User Requirements.

●Supported in Pre-UAT and UAT sessions.

●Supported testing and business user training activities as part of OCM for GPLM system release.

●Worked closely with multiple departments within the organization – such as Business, IT, Development and Quality Assurance.

●Developed and Implemented changes to Foster city-controlled documents (e.g., Specifications, SOPs etc.).

●Lead document coordination effort for GPLM project. Coordinated with Business leads of all Gilead sites to ensure timely revision and completion of site SOPs and Specifications.

●Coordinated review, approval of controlled documents (SOPs, Work Instructions, Forms and Business Enabling document).

●Performed Item data reconciliation to ensure data integrity between Supply Chain systems e.g.GPID and GPLM-EBS.

●Processed GPLM Change Order as per PDM Standard Operating Procedures.

●Provided daily / weekly project progress status reports and escalate issues as required.

GVault Project

●Prior to GPLM, worked on GVault releases (Veeva Vault - Quality Management System)

●As a Vault administrator configured, granted user access and generated customized reports.

●Build and run Veeva Vault QualityDocs reports.

●Support training activities and participate in testing and verification of system functionality during UAT/PQ.

●Collaborated with business process owners to gather and understand business requirements and author/review URS (user requirement specifications) document for GVault Enhancements and Contractor Manual (Veeva Vault product).

●Worked closely with Validation Change Owners from Engineering, Manufacturing and IT to plan & draft validation protocols, assure proper execution/documentation of test results.

●Authored change control details in Track wise system for implementing the enhancements

●Authored IQ, OQ, PQ, validation plan, traceability matrix, discrepancy forms and validation summary reports.

●Ensured validation documentation is in compliance with organization policies and procedures.

●Supported in managing user change requests and change process for GVault project.

●Ensured validation packages contain all relevant information, rationales, references, and data.

●Participated in peer review of validation test scripts and test readiness review.

●Developed Risk Assessment and RTM and perform dry run testing.

●As part of partner collaboration project, coordinated with vendor resources from Veeva Vault. Worked with technical personnel to define the appropriate configuration requirements for GVault to meet the requirement.

●Worked closely with multiple departments within the organization – such as Business, IT, Development and Quality Assurance.

●Worked with business process owners and technical team to confirm system is aligned with requirements.

●Participated in testing and validation of the system functionality enhancements

●Represented GVault in an Expo for business users as part of OCM (Organizational change management) and conducted onsite training for them.

●Supported testing and business user training activities as part of OCM for GVault system release.

●Implemented process improvement by setting up and managing the HP ALM tool for GVault project.

IQS Project

●Prior to GVault, worked on Integrated Quality System (IQS) for managing the lifecycle of quality records used in Quality Assurance (QA) workflows related to manufacturing and release of materials for clinical (API and Drug Product) and commercial active pharmaceutical ingredient (API).

●Performed manual testing of application including functional and regression testing for enhancements.

●Perform quality control checks & peer review of data quality & documents

●Created Change Management request, Deviation and CAPA in Track-wise and using root cause analysis tools for identifying and correcting deviations.

●Perform risk assessment for projects & change requests, supports in writing the change controls for various PR.

●Participate in discrepancy investigations

●Worked with multiple cross-functional teams to support the creation and revision of processes and procedures for IQS project.

●Participated in testing and validation of the IQS system functionality enhancements.

●Implemented process improvement by setting up and managing the HP ALM tool for IQS project.

Project Lead/Software Quality Assurance (SQA) May 2015 - Feb 2016

Gilead Life Sciences, USA (IT)

●Planned, and managed successful delivery for 2 projects (Partner Account Management (IDM) & EBS Access Automation Enhancement) within agreed cost and timescale, exceeding the quality standards and customer expectations in Managed testing services (MTS) model.

●Partner Account Management: Tested SailPoint based Identity Management application and integration with LDAP for accessing active directory. This application to manage application access for all Gilead Partner users (e.g. labs, ad agencies, etc.).

●EBS Access Automation Enhancement: automatic provisioning of access and multiple access request enhancements – Internal access requests for Oracle EBS were fully automated. Key technologies: Oracle ERP EBS application, OBIEE/HRA, Planning & Demantra and Oracle SQL developer.

●Based upon agreed scope, estimated resources, prepared and tracked budget / resource assignments.

●Analyzed Business Requirements & System Specifications and performed ambiguity review.

●Prepared Test Plan, reviewed and secured approvals with key project stakeholders.

●Developed test scenarios using Fish-bone diagram technique, test cases, test data and review these with business and development teams.

●Created and tracked test execution plan.

●Facilitated consistent communications between customer & onshore/offshore teams and integrate work deliverables into a seamless solution for customer.

●Identified, analyzed and managed risks / issues and escalations. Devised and communicated risk / issue mitigation plans with relevant stakeholders.

●Configured and customized HP-ALM: creating releases, cycles, uploading requirements, traceability matrix, configuring defect fields, reporting using analysis and dashboard views.

●Created and provided QA metrics reports demonstrating data-driven analysis and defect prevention.

●Reviewed and executed of validation protocols.

●Managed Daily Defect triage calls with Dev team, business analysts, project manager and business users to review, prioritize defects and assisted in their resolution.

Test Lead / Business Analyst: HSBC Software Development Center - May 2005 - June 2011

●Extensive experience in One HSBC Deposits Core Product Enhancement for HSBC Software House, Canada. Knowledge of risk management in capital markets.

●Managed a team of 16 resources for functional testing of project which deals with facilitating International Trade via Internet involves various services like submission of application of documentary credit (DC) thought internet, amending already submitted application, enquiring facilities bank offer

●Gathered requirements, prepared business requirement documents and reviewed functional specs.

●Act as a liaison between business units and technology teams and support with complex query resolution.

●Conduct Impact & Gap Analysis of system and prepare high-level design flows, use cases & activity diagrams for certain required developments.

●Imparting trainings to testing, development and technical writing team on functional areas.

●Planned, and managed successful delivery for multiple projects within agreed cost and timescale.

●Responsible for Software Configuration Management and handling Quality Audits.

●Strong exposure to Software Development Life Cycle and Software Test Life Cycle.

●Analyze risks, devise mitigation plans and identify / escalate issues to relevant stakeholders.

●Preparing Project Status Reports & responsible for the process like Internal Audit etc.

Software Test Engineer: - May 2003 - Apr 2005

●Configuring Accelenet Client and Server

●Creation of Test Design Specification and creation of coverage Matrix for assigned modules.

●Created Knowledge Base Document of Client-Install/Uninstall.

●Test execution & defect tracking & analysis.

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