Divya Loganathan Email & Phone Number

Bengaluru, Ka, In

India

Bangalore

• Determine the Validation Strategy along with the Client Compliance Team.• Author Validation Master Plan, IQ & OPQ Protocol, Validation Summary Report.• Review Cloud Infrastructure Design, Infrastructure Failure mode effect Analysis, Risk Assessment Report, Infrastructure Test Script, IQ and OQP Test Scripts, Execution Log, Traceability Matrix, Disaster Recovery plan for GDP Compliance.

Bengaluru Area, India

• Estimate Project Timelines, on-board resources• Author Software Validation Plan, Test Strategy and Validation Summary Report.• Review Regulatory Risk Assessment, 21CFR Part11 Assessment checklist, Functional Risk Assessment, Disaster Recovery Plan.• Perform GAP , RCA Analysis• Organize the status meetings and send the Status Report (Monthly, Daily, Weekly etc.) to the Client/Senior management.• Review Test Scenario, IQ Test cases and execution logs as per GDP Guidelines.• Create/ Review OQ, PQ Test cases as per GDP Guidelines.• Execute OQ Test Cases electronically through HP ALM / through paper based validation.• Participate in Defect Triage meetings, Internal /Client Audit.• Identification of any deviations from the Test Strategy, the reason why, the impact and what mitigating actions were taken

Bangalore

• Understand the testing effort by analysing the requirements of project.• Estimate the time, resources and budget required to perform the testing.• Organize the Testing Kick off• Build a testing team of professionals with appropriate skills, attitudes and motivation.• Establish Software Validation/Test Plan, Test Strategy and Validation/Test Summary Report • Review Tool Risk Assessment , 21CFR Part11 Assessment check list, Functional Risk Assessment, • Perform Gap Analysis• Document, implement, monitor, and enforce all processes for testing as per standards defined by the organization.• Monitor and Report on validation progress• Organize the status meetings and send the Status Report (Daily, Weekly etc.) to the Client• Together with the QA, ensuring that the criticality of the corrections to the computer system is evaluated and documented• Review and Approve IQ, OQ and PQ test cases created by the Team.• Review and Approve IQ, OQ and PQ Execution logs.• Review and Close defects• Identification of any deviations from the Test Strategy, the reason why, the impact and what mitigating actions were taken• Tracking Metrics, Efforts, Review comments in the organizational tool

Coimbatore

• Identifying the change in the functional requirement documents and the design documents which occurred as a result of new requirements • Create Test Cases• Peer Review, Test Execution & Defect management.• Preparation of project closure metrics preparation in order to share with the client.• Tracking Efforts, Review comments in the organizational tool Cognizant 2.0