Validation consultant

We are looking for a CSV Consultant with 5+ years of experience in Computer System Validation within a GxP-regulated environment. The consultant will ensure that computerized systems comply with applicable regulatory requirements and industry standards.

 Key Responsibilities:

• Prepare and review validation documents, including URS, risk assessments, validation protocols, test scripts, and validation summary reports.
• Execute CSV activities in accordance with GxP requirements and company SOPs.
• Ensure compliance with FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and data integrity principles (ALCOA+).
• Support IQ/OQ/PQ, UAT, defect management, deviation handling, and change control activities, as applicable.
• Perform validation impact assessments and maintain requirements traceability.
• Collaborate with IT, Quality Assurance, and business teams to ensure audit readiness.

Required Skills:

• Hands-on experience in CSV within pharmaceutical or life sciences environments.
• Knowledge of GxP regulations, risk-based validation, and SDLC.
• Experience with validation documentation and testing tools such as HP ALM, Qtest, Jira and Veeva QMS.
• Strong documentation, analytical, and communication skills.