CSV/Validation Entry-Level Analyst Resume Title

SANGITA RAJGOPAL

Morrisville, NC (Open to roles in Holly Springs / Raleigh)

984-***-**** ️ *******.********@*****.***

PROFESSIONAL SUMMARY

Detail-oriented professional transitioning into the pharmaceutical and life sciences industry with a focus on Computer System Validation (CSV), GMP compliance, and quality documentation. Brings 10+ years of experience in regulated environments, documentation control, cross-functional coordination, and client support. Proven ability to manage processes, ensure compliance, and support audit-ready documentation. Actively upskilling in CSV, GMP, and validation processes to contribute effectively in entry-level validation or quality roles. Actively seeking entry-level opportunities in CSV, QA, or validation within pharmaceutical/biotech environments in North Carolina

CORE SKILLS

GMP Awareness & Compliance (Training in Progress)

Computer System Validation (CSV) Fundamentals

Documentation & SOP Writing

Quality Assurance Support

Data Integrity & Compliance

Cross-functional Coordination

Root Cause Analysis (Basic)

Customer Support & Process Management

SAP Basis (User Access & Authorization)

Regulatory Documentation Support

PROFESSIONAL EXPERIENCE

Advisory Consultant – Materials & Business Support

Self-Employed May 2024 – Present

Coordinate with clients and suppliers for raw material sourcing and order processing

Maintain structured documentation for transactions, contracts, and communication

Support compliance-related documentation and process tracking

Collaborate with cross-functional stakeholders to ensure smooth execution of operations

Business Development & Customer Support Roles

Multiple Organizations India Prior Experience

Managed end-to-end customer lifecycle including onboarding, order processing, and issue resolution

Prepared proposals, quotations, and client documentation in structured formats

Coordinated with internal teams (operations, finance, logistics) to ensure timely delivery

Maintained accurate records and documentation aligned with business and compliance requirements

SAP Basis & Authorization Support

Reliance Info Solutions / Ventura-Capita India Pvt. Ltd.

Managed user access control and role-based authorizations in SAP systems

Ensured compliance with data security and audit requirements (including GDPR-related processes)

Supported system documentation, audit readiness, and compliance tracking

Collaborated with cross-functional teams to resolve access and system-related issues

Freelance Translator (Part-Time)

Translated legal, scientific, and technical documents across multiple languages

Ensured accuracy, consistency, and adherence to domain-specific terminology

Worked on structured and compliance-sensitive content

EDUCATION

Bachelor’s Degree (Relevant discipline)

ADDITIONAL TRAINING (IN PROGRESS)

Computer System Validation (CSV) Fundamentals

Good Manufacturing Practices (GMP) Basics

Pharma Quality Systems & Documentation

TOOLS & SYSTEMS

SAP (Basis & Authorization)

MS Excel, Word, PowerPoint

Documentation & Reporting Tools

Learning: Validation tools (e.g., Kneat – awareness level)

KEY STRENGTHS

Strong documentation and compliance mindset

Ability to quickly learn regulated processes

Excellent communication and coordination skills

Detail-oriented with focus on accuracy and quality

Adaptable to new environments and technologies

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