GxP Testers with Validation Experience

This is a permanent work from home position from anywhere in India

Notice period - less than 30 Days (Immediate joiners preferred)

We are seeking a Senior GxP Tester with Validation Experience to ensure compliance with GxP regulations in pharmaceutical, healthcare, and life sciences applications. The ideal candidate should have expertise in validation testing, regulatory compliance, and defect management.

Key Responsibilities:

• Perform GxP-compliant software testing for regulated systems.
• Develop and execute validation protocols (IQ, OQ, PQ).
• Ensure adherence to FDA 21 CFR Part 11, GAMP 5, and other regulatory standards.
• Prepare and review validation documentation (test scripts, traceability matrix, validation reports).
• Identify, log, and track defects while ensuring compliance.
• Collaborate with stakeholders to ensure audit readiness and data integrity.

Required Skills:

• GxP, FDA 21 CFR Part 11, GAMP 5 Compliance
• Validation Testing (IQ, OQ, PQ)
• Test Strategy, Execution & Defect Management
• Regulatory Documentation & Compliance Audits
• Tools: HP ALM, JIRA, TestRail, Veeva Vault QMS (Preferred)