Computer system vali

Job Title: CSV Analyst (Computer System Validation)

Location: Bangalore, India

Experience: 7+ Years

Job Summary:

We are seeking an experienced CSV Analyst with a strong background in Computer System Validation (CSV) within the healthcare/pharmaceutical domain. The ideal candidate will have extensive experience in validation, verification leadership, and regulatory compliance, ensuring that systems meet industry standards such as GxP, FDA, and other global regulations. This role requires hands-on expertise in validation lifecycle management, documentation, and cross-functional collaboration.

Mandatory Skills & Experience:

• 7+ years of overall experience in Computer System Validation.
• Minimum 5 years of Senior Validation experience handling complex validation projects.
• At least 5 years of experience as a Verification Lead, managing validation strategy and execution.
• 2+ years of experience in Regulatory Affairs with exposure to global compliance standards.
• Healthcare / Pharmaceutical domain experience is mandatory.
• Strong knowledge of:
• GxP (GMP, GLP, GCP)
• FDA 21 CFR Part 11 compliance
• GAMP 5 guidelines
• Hands-on experience in validation of systems like LIMS, QMS, ERP, Clinical systems, etc.