Rashmi M.
About Rashmi M.
Rashmi M. is a Validation Engineer at Alkermes in Waltham, Massachusetts, with extensive experience in FDA and MHRA compliance, specializing in the full validation life cycle and computerized system validation.
Title
Rashmi M. is a Validation Engineer currently working at Alkermes in Waltham, Massachusetts, United States. She has extensive experience in the field of validation engineering within regulated environments.
Previous Work Experience
Rashmi M. worked at Bristol Myers Squibb as a Validation Specialist from 2020 to 2022. During her two-year tenure, she demonstrated her expertise in 21 CFR part 210, 211, and 820 compliance and the GAMP 5 approach. Her key responsibilities included developing and reviewing user requirement specifications, functional requirement specifications, and design specifications in compliance with FDA and MHRA regulations.
Educational Background
Rashmi M. studied at the University of Iowa where she earned her Bachelor’s degree in Microbiology, General. She attended from 2013 to 2015. Her academic background has provided a solid foundation for her career in validation engineering and regulatory compliance.
Validation and Compliance Expertise
Rashmi M. has full validation life cycle experience, including developing and maintaining Software Development Life Cycle (SDLC) for validated systems. She has developed and reviewed test plans, validation protocols (IQ, OQ, PQ), test summary reports, and requirement traceability matrices. She is skilled in conducting GAP analyses and resolving gaps, developing corrective and preventive action plans (CAPA), and preparing various regulatory and risk assessments for FDA-regulated environments.
Technical Skills
Rashmi M. possesses technical skills in manual testing and has extensive experience with HPALM (Quality Center) for managing testing. She has validated computerized systems such as FastTrack, GDR, LIMS, TrackWise, and SharePoint. Her expertise in Good Documentation Practices (GDP), change management, risk analysis, and conducting periodic reviews of active applications make her a valuable asset to any organization in the validation engineering field.