Sai Sindhu B

Senior Validation Consultant @AstraZeneca

Rockville, MD, US

Perform Commissioning, Qualification, and Validation of Equipment, Utilities, and Facility in the cGMP Facility.Generate, review, and execute Installation Qualification/ Operational Qualification/ Performance Qualifications (IQ/OQ/PQ).Conduct FAT and SAT for utilities and equipment.Ensure proper calibration and maintenance schedules are in place for critical utilities and equipment.Verify equipment performance against specified requirements.Validate cleanroom conditions. Conduct smoke studies, airflow tests, and particle count testing for cleanroom and controlled environments. Write technical reports on commissioning, qualification, and validation activities. Implement change control procedures for modifications to utilities and facility systems during commissioning. Ensure proper documentation of any system changes, including impact assessments.Collaborate with Engineering and Operations Teams: Work closely with engineering and operations teams to ensure systems are properly commissioned, installed, and tested. Generate reports from Equipment or Room Monitoring System (EMS/RMS) and Building Monitoring System software such as trend data (min, max, and avg) and Graphs using Info Center Software application for various parameters such as temperature, humidity, and CO2%.Provide guidance to operations teams on system startup and maintenance procedures.Compliance and Regulatory Review.Ensure validation and commissioning work complies with regulatory guidelines and internal GMP requirements. Address & Draft deviations when the test results failed to meet the acceptance criteria, performing root cause investigation & impact assessment, implementing corrective actions, and documenting the justification for acceptance after implementing corrective actions.Work with QA/Compliance to track and coordinate any validation change control and/or corrective actions.

Long Island University

Master's degree

Manipal Institute of Technology

Bachelor's degree