Sagarika Majumdar

Project: Major Critical GxP projects

Period: FEB 2022 till date

Role: Computerized System Validation (CSV) Lead

Tools used: HP ALM, JIRA, Confluence, ServiceNow

Solution Environment: Windows, Citrix Workspace

Client: Client is a 50-year-old global pharmaceutical company with headquarters in France, committed to research, development, manufacturing, and marketing of novel products of high therapeutic value for human and veterinary medicine.

Highlights: Worked at Client's location in France for 01 year.

Responsibilities:

• Validated the SDLC Documentation- User/Functional Requirement Specification, Design Spec, Functional Risk Assessment, Testing documents.
• Preparing a complete Validation plan considering all the regulations and the possible testing scenarios for the system with respect to all the agreements.
• Validated Testing in HP-ALM & JIRA/Confluence
• Client Management – Interacting with client to ensure seamless delivery
• GxP assessment for Change Request in ServiceNow
• Defining Testing strategy for Change Request in ServiceNow.
• Validation and Approval of Change Request in ServiceNow before/after assessment and before deployment.
• Provided coaching, guidance and support to the IT personnel in QA/QC Review of SDLC deliverable and activities in regard to SOP, policies and current regulation to ensure compliance.
• Vendor assessment through questionnaire, third party audit.

Project: Veeva CRM project

Client: UK based Pharma company

Period: DEC 2015 to FEB 2022

Roles: Validation Test Lead, Computer System Validation Lead

Solution Environment Windows, VMWare

Tools: HP ALM, JIRA, SQL Developer

Client: The client is one of the top pharmaceutical companies in the world, and a member of Fortune-500 elite list, with its presence in across the Globe.

Responsibilities:

• Extensive Validation Testing experience
• Validated the SDLC Documentation- User/Functional Requirement Specification, Design Spec, Functional Risk Assessment, Testing documents.
• Execution of GxP regulated Projects and ownership for all deliverables to customer and tracking overall deliverable status.
• Train and mentored the team members on tools and IT Quality Concepts
• RFP preparation – Project Estimation – Proposal
• Facing Audit, Metrics preparation, Forecasting
• SOW preparation - Work Order submission and approval
• Project requirement understanding and analysis.
• Participated in the knowledge transfer as a part of the transition process team.
• Conducted external hiring interview drive.
• Risk Management, BCP coordinator, Escalation Handling

• Devise, implement, and enforces policies, practices and tools for function, validity, performance, and reliability testing.
• Reviews results of major and final tests to determine if delivery specifications are met in line with requirements and standards.
• Monitors and evaluates testing practices and tools to improve the testing process and quality of test results.
• Oversees performance of teams.
• Plan and lead release and system acceptance testing, collaborating with development, project managers and vendors to create and execute test plans and test cases.
• Review requirements to provide feedback on completeness, test-ability and other risk areas that could impact delivery quality.
• Perform regression, system acceptance and other relevant testing.
• Identify, replicate, document, prioritize and track issues to closure.
• Educate team members across the organization regarding the quality function and their role in ensuring quality standards are met.
• Produce quality metrics, testing results and other reports for all levels of management.

Project: Enterprise Information Management

Client: UK based Audit Company

Period: AUG 2014 to AUG 2015

Roles: Senior Consultant

Tools HP ALM, JIRA, SQL Developer, TOAD, MySQL, TFS

Description: Project aims at maintaining record of each & every associate joining a company, creating unique ID, mailbox, privilege and provide access, certifications to various applications, maintaining access till the off-boarding procedure from that organization

Responsibilities:

• Extensive Software Testing experience
• End-to-end software testing from requirement analysis to system study, test case designing, test execution, logging defects.
• Involved in defect de-bugging too.
• Defect verification and defect closure
• Cover client's requirements effectively with the test scenarios and providing them best solutions involving evaluation & definition of the scope of the project

Description: At HSBC client location, handling multiple projects as a module lead. The projects are based on Personal Internet Banking, Business Internet Banking and Private Banking. Projects are aiming at amendments of new enhancement on front end and backend (Mainframe), with some of the implementation on the staff channel.

Highlights:

• Attending client calls for requirement understanding and project status.
• Planning different tasks for each team member.
• Preparation of test cases, test data, test plan, RTM, Reports
• Execution of test cases in Quality Centre.
• Raising the defects using the Quality Centre against appropriate streams with appropriate details
• Follow up with appropriate teams after raising the defects and bring it to closure.
• Recipient of the several accolades in recognition of excellent performance in multiple projects.

#Role - Technical Associate (Tester)

Project duration – February 2010 till June 2011

Description: Etisalat DB Telecom and its subsidiary signed a Letter of Intent with Tech Mahindra to manage the IT applications and infrastructure needs for its proposed roll-out across 15 circles. Etisalat plans to launch its wireless (2G) operations in different parts of India targeting around 75 million subscribers in the first 10 years.

Highlights:

• As a Team Member (with a team size of 15) of the Testing Group was responsible for the follows-
• Preparing Test Cases and Test Scenarios from the end-to-end perspective for all the components.
• Raising the defects using the JIRA against appropriate streams with appropriate details.
• Follow up with appropriate teams after raising the defects and bring it to closure.
• Supported UAT at client location
• Received the Best Manual Software Tester Award for outstanding performance

#Role - Technical Associate (Tester)

Project duration – November 2008 – January 2010

Project Name – Cox Peach (MVNO & BOT)

Tools: Seibel CRM, Quality Centre

Description: Cox Communications, subsidiary of Cox Enterprises providing cable and telecommunications wireless services in the USA and offers a wide range of cable and wireless products and services. Tech Mahindra Ltd. is doing the systems integration to facilitate COX Telco operations. Operation to be supported through tools of Oracle stack relates to Customer Relationship Management, Billing and Revenue Management, Product Management, Order and Service Management etc.

Responsibilities:

• Preparing Test cases for executing end-to-end test scenarios.
• Component integration testing, System Integration Testing and Regression testing for the overall system.
• Execution of Test Cases and raising defects in the Quality Centre
• Going through the updated comments in the Quality Centre and doing retesting for solved Defects.
• Attending various conference calls, to track project status and management reviews within the project.