Ruba Ruba M Mohanraj
Validation Consultant | CSV | GxP | Regulatory Compliance
- Role
- Solution Delivery Advisor at Deloitte
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Ruba Ruba M Mohanraj
Experienced in validating scientific applications used in GxP and non-GxP environments with primary responsibilities in Project Management, creation and review of Validation documents created as part of end-to-end validation.Acquired knowledge on Computer System Validation and Assurance concepts, FDA regulations like 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, EU Annex 11, EU Annex 15, EU Part 1, EU Part 2, Japanese ERES and guidelines like GLP, GCP, GMP & GAMP 5; GDPR, Data Integrity; SEND, CDISC standards.Owned communications with customers and vendors to communicate project status including timeline, foreseen risks and mitigation plans.Possess hands-on experience on the tools - HpALM, qTest, ServiceNOW, Kneat.
Experience
Solution Delivery Advisor
Aug 2025 — Present · Bengaluru, IN
Education
Annamalai University
Master of Arts - MA, Sociology
Sri Sivasubramaniya Nadar College Of Engineering
Bachelor of Engineering, Biomedical engineering
2016 — 2020
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