farzana banu

Software verification on Medication Delivery Systems - Embedded Testing - Infusion Pumps (LVP , Syringe,
PCA Pumps ), Web Application testing along with Machine Learning Systems, System Testing and
Connectivity System Testing (CSYRS).
 Led Manual Testing / Automation Script reviews, Keyword Driven Framework - Product Testing, Medical
Device Testing, Simulators, Embedded Software Testing, Product Development Lifecycle Management
(PDLM) Practices.
 Thorough understanding and knowledge on ISO13485 and Good Documentation Practices. Knowledge of
regulatory requirements (FDA 21 CFR Part 11 and GAMP Levels)
 Excellent leadership skills managing a team size of 7. Face of the project, responsible for client
communication, client reporting, internal stakeholder management, accurate progress reporting and prompt
issue resolution throughout the project life cycle.

Responsibilities included the following:
 Review and analyze requirements as part of test development.
 Plan, prepare, develop and execute verification test methods, protocols, and reports for verification.
 Design test cases, include test methodology, test setups, materials, equipment, procedure, and acceptance
criteria based on requirements.
 Collaborate with cross functional teams,highlight risks,resolve all the dependencies and solve technical issues
faced by the team.
 Review, Author, Execute, perform, summarize, report out verification & validation test activities of
components to a full system device which includes Test Plans, Test Procedures, User & Functional
Requirements testing, Design Verification Protocols, Traceability Matrices and Final Reports.
 Good exposure to Computerized System Tool Validation. Have played System Owner role in Tool Validation
Projects.
 Review and approve validation documentation, including Validation Plans (VP), User Requirements
Specifications (URS), Functional Requirement Specifications (FRS),Installation Qualification (IQ),
Operational Qualification (OQ) and Performance Qualification (PQ)
 Day-wise tasks to the team, track progress and providing technical support to troubleshoot the problems faced.
 Drive quality into product development through analysis, test and timely feedback of test results to the crossfunctional
team. Document, manage and maintain test records consistent with formal test processes and
Quality Management System policies and procedures.
 Identify issues early. Refine the test plans and procedures through pre-verification / Dry runs. Play a front end
role in internal audits and quality reviews.
 Support the compliance team/ closure of internal Regulatory and Quality requirements before delivering any
deliverables to the client.
 Collaborate with the automation team to improve overall automation coverage.
 Own and drive the entire verification activity, perform root cause investigations and develop solutions. Drove
customer satisfaction by providing suggestions that improved current test strategy and approach.
 Attend internal and external stakeholders meetings, reporting the status of project to the management,share
progress and timeline of the project.

Master of Engineering - Software Engineering