Sindhura Mamduri

Operations Associate

Hyderabad, Telangana, India11 yrs 9 mos experience
AI ML PractitionerHighly Stable

Key Highlights

  • Over a decade of experience in CSV and IT Quality.
  • Specialized in regulatory compliance for pharma and medical devices.
  • Led complex validation programs and digital transformation initiatives.
Stackforce AI infers this person is a Life Sciences Compliance Expert with a focus on IT Quality and Regulatory Standards.

Contact

msindhura1992@gmail.comLinkedIn

Skills

Core Skills

Computer System ValidationRegulatory ComplianceUser Acceptance TestingIt Risk Management

Other Skills

IT QualityGxP Program ManagementAI/ML governanceDigital transformationInstallation QualificationPharmaceuticalsIT AuditTraining ManagementWorkload PrioritizationSystem TestingGood Manufacturing Practice (GMP)Analytical SkillsProduct DevelopmentQuality ControlProduct Lifecycle Management

About

I am part of EY's Life Sciences practice, with over a decade of experience in Computer System Validation (CSV), IT Quality, Regulatory Compliance, and GxP Program Management. I am specialized in enabling pharmaceutical and medical device clients to meet 21 CFR Part 11, Annex 11, and GAMP 5 requirements through validated systems and scalable quality frameworks. Currently a Manager at EY GDS, I support global teams on complex validation programs, AI/ML governance initiatives, and digital transformation efforts across R&D, Manufacturing, Quality, and Commercial functions. I have worked with 10+ pharma clients, helping streamline compliance processes and deliver audit-ready systems.

Experience

11 yrs 9 mos
Total Experience
4 yrs 10 mos
Average Tenure
2 yrs
Current Experience

Ey

Manager

Jun 2024 – Present · 2 yrs · Hyderabad, Telangana, India · Hybrid

Computer System ValidationIT QualityRegulatory ComplianceGxP Program ManagementAI/ML governanceDigital transformation

Deloitte

Senior Solution Delivery Lead

Jul 2018 – Jun 2024 · 5 yrs 11 mos · Hyderabad, Telangana, India

User Acceptance TestingInstallation Qualification

Tech mahindra

Computer System Validation Consultant

Sep 2014 – Jul 2018 · 3 yrs 10 mos

User Acceptance TestingIT Risk Management

Education

National Institute of Technology Warangal

Bachelor of Technology (B.Tech.) — Biotechnology

Jan 2010 – Jan 2014

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