Ragini g

Oversaw site-wide validation and calibration for equipment, utilities, facilities, cleaning, and computerized systems, ensuring compliance with FDA, MHRA, EMA, and Health Canada regulations. Led process validation for scale-up batches and routine production, managed change controls, CAPAs, and investigations, and developed/executed validation plans and technical documentation. Implemented in-house

Responsible for planning validation activities and managing calibration/re-qualification programs for various equipment and computerized systems. Authored, reviewed, and approved validation protocols, SOPs, and calibration test methods, collaborating with quality teams on change controls, CAPAs, and investigations. Managed cleaning validation schedules and supported deviations, also serving as int

Developed various documents including validation plans, protocols, annual summary reports, and SOPs for equipment and software systems, along with Part 11 assessment reports and IQ/OQ. Served as a Computer Validation SME for systems like Trackwise and Documentum, managing Change Control and CAPA programs. Authored and reviewed qualification documents for instruments and assisted in resolving inter

Analyzed business requirements and prepared validation plans, assisting in executing test plans and writing test cases using Quality Center. Supported change controls, CAPAs, and deviations via Trackwise, performing root cause analysis for corrective actions. Developed IQ, OQ, and PQ protocols and maintained Requirement Traceability Matrix (RTM).

Assisted in documenting and reviewing the Quality system to ensure compliance with hospital regulations. Trained medical staff on instrument handling and software usage. Discussed compliance handling and device reporting issues with medical professionals and staff.

Collaborated with software and hardware engineers to develop a fully automated pathological analyzer, overseeing product development from planning to execution. Conducted quality control checks, performance testing, and data analysis for critical defects. Performed risk analysis, developed software validation procedures, and maintained GMP in accordance with ISO 13485 requirements.

Worked in a team of software and hardware engineers to scale up a 3-channel ECG design to a 12-channel ECG on a smaller integrated circuit board. Involved in designing the electrical circuit using PCB design software and successfully running the output of the electrocardiograph.

Activities and societies: Worked as GA and RA

Pursued a Master of Science degree in Biomedical Engineering. Gained experience as a Graduate Assistant (GA) and Research Assistant (RA) during the program.

Completed a Bachelor of Science degree in Biomedical Engineering. Focused on foundational engineering principles relevant to medical applications.