CSV Consultant - Freelancer

Engaging Senior CSV Professionals (Contract Basis) India

As regulatory expectations around digital systems continue to tighten, we are expanding our Computer System Validation (CSV) capability for upcoming GMP programs.

We are looking to engage experienced CSV professionals (contract basis) who can independently drive end-to-end validation programs for regulated pharmaceutical environments.

What We Are Looking For

Professionals who can lead and execute the complete lifecycle of Risk-Based Computer System Validation, including:

Driving validation activities for new GMP applications and ongoing product releases

Deep understanding of Risk-Based CSV aligned with GAMP 5

Strong regulatory exposure: USFDA, EMA, ICH, GxP, 21 CFR Part 11

Hands-on experience in Risk Assessments (FMEA / RA)

Managing compliance events and change management

Technical Expertise Required

Development of Validation Plans

Risk Analysis & Impact Assessments

IQ / OQ / PQ protocol authoring and execution

Requirements Traceability

Lifecycle documentation management

SOP authoring and review

Validation Summary Reports

Cross-functional collaboration ensuring lifecycle compliance

We are specifically looking for professionals who:

Can operate independently in client-facing environments

Understand regulatory inspection expectations

Have strong documentation capability (not just reviewers)

Bring structured, risk-based thinking

Location: India Engagement: Contract basis (project-driven)

Educational Qualifications: BE/B.Tech/B.Pharm