Job Description
Job Title: CSV Expert (Computer System Validation Specialist)
Department: Quality Assurance / Validation
Location: Vadodara

Employment Type: Full time

Reports To: Head of Quality / Validation Manager

About Topia LifeSciences

Topia LifeSciences is a forward-thinking organization committed to delivering high-quality
solutions to the life sciences industry. We strive to ensure regulatory compliance, operational
excellence, and innovation across pharmaceutical, biotech, and medical device sectors. As we
continue to grow, we are seeking a skilled Computer System Validation (CSV) Expert to
join our quality team and support our expanding portfolio of regulated systems.

Role Summary

As a CSV Expert at Topia LifeSciences, you will be responsible for ensuring that all
computerized systems used within GxP environments are validated according to applicable
regulatory standards and internal procedures. You will work cross-functionally with QA, IT,
engineering, and operations teams to ensure data integrity, regulatory compliance, and audit
readiness.

Key Responsibilities





• Lead and execute full lifecycle validation activities for GxP-regulated systems (e.g.,
LIMS, ERP, MES, QMS, lab instruments).
• Prepare and review CSV documentation including:
o Validation Plans (VP)
o User Requirements Specifications (URS)
o Functional Specifications (FS)
o Risk Assessments
o IQ/OQ/PQ Protocols and Reports
o Traceability Matrices
o Validation Summary Reports
• Ensure compliance with global regulatory requirements including:
o 21 CFR Part 11
o EU Annex 11
o ICH Q9/Q10
o GAMP 5
o Data Integrity Guidelines (ALCOA+)
• Collaborate with IT, QA, engineering, and business stakeholders for system
implementation, upgrades, and revalidations.
• Support audit readiness and participate in regulatory and client audits.
• Conduct gap assessments of existing systems and recommend validation strategies.
• Provide SME support on deviation investigations, CAPAs, and change controls.
• Mai

📌 CSV Expert (Vadodara)
🏢 Topia Pharma Intelligence
📍 Vadodara