GxP Validation Specialist - SQL

Position : GxP Validation Specialist

Experience : 5-6 Years

Location : Chennai / Pune

Employment Type : Full-time

Job Summary :

We are seeking a GxP Validation Specialist with 5-6 years of hands-on experience in Computer System Validation (CSV) and regulatory compliance within the life sciences domain. The ideal candidate will be an expert in ensuring systems adhere to GxP requirements and be responsible for the full validation lifecycle, from authoring validation deliverables to executing test cases. This role requires a strong understanding of 21 CFR Part 11 and Annex 11, as well as proficiency in SQL for database verification.

Key Responsibilities :

Validation & Compliance :

• Provide SME-level support in GxP compliance, Computer System Validation (CSV), and regulatory guidelines like 21 CFR Part 11 and Annex 11.
• Ensure all validation activities are aligned with a risk-based approach.

Test Case Management :

Documentation & Reporting :

Technical Verification :

Required Skills & Experience

Core Experience :

Technical Proficiency :

Soft Skills :

(ref : hirist.tech)