Join our Enterprise Technology & Performance team as a Consultant, specializing in Computer System Validation (CSV) for the Life Sciences and Healthcare industry. We are seeking a seasoned professional with over 5 years of experience to lead validation activities for critical enterprise applications. This role is based in Hyderabad and offers an exciting opportunity to drive innovation and ensure compliance within a dynamic environment.

As a Consultant, you will spearhead end-to-end validation processes for GxP-regulated computerized systems, including ERP, LIMS, QMS, and MRP. You will act as a Validation Subject Matter Expert, contributing to business requirements, technical designs, and test strategies. Key duties include defining validation approaches for agile delivery, performing validation for IT projects and system upgrades, and ensuring systems maintain their validated state through periodic reviews and deviation handling. You will also conduct risk assessments, manage change requests, and support supplier evaluations.

We are looking for a Computer System Validation expert with a minimum of 5 years of hands-on experience in quality assurance within the life sciences and healthcare sectors. A strong understanding of regulatory requirements such as GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 is essential. Proficiency in validating enterprise-level applications and experience with data migration, cloud validation, and supplier assessments are highly valued. Excellent communication, problem-solving, and collaboration skills are crucial for success in this role. A Bachelor's degree in Engineering or Technology (BE/B.Tech) or any full-time graduation is required.