Join our dynamic team as a Consultant, specializing in Computer System Validation (CSV) for SAP within the Life Sciences and Healthcare sector. This role offers an exciting opportunity to leverage your expertise in a critical industry, contributing to the integrity and compliance of enterprise systems. Be part of a forward-thinking environment where innovation and quality are paramount.

We are seeking a seasoned professional with a proven ability to manage end-to-end validation processes for complex enterprise applications. Your contributions will be vital in ensuring our clients meet stringent regulatory requirements and achieve operational excellence. This position is based in Hyderabad, India.

Lead Computer System Validation (CSV) activities for GxP-regulated computerized systems in Life Sciences and Healthcare. Drive the development of validation strategies, ensuring agility and rapid delivery of solutions. Define and execute comprehensive validation plans for IT projects, system releases, and upgrades.

Collaborate with stakeholders to build strong working relationships and ensure validation needs are met. Create and review crucial validation deliverables, including GxP Assessments, Validation Plans, URS, FRS, DS, IQ, OQ, and PQ. Oversee data migration validation for critical systems, alongside exposure to cloud, AI/ML, and infrastructure validation.

Manage deviation handling, performing Root Cause Analysis (RCA) and implementing Corrective and Preventive Actions (CAPA). Handle change requests during the operational phase and conduct thorough requirement and IT risk assessments. Support supplier assessments and provide expert guidance. Contribute to internal audits and inspections, ensuring compliance and adherence to best practices.

A minimum of 5 years of dedicated experience in Quality Assurance and/or Computerized System Validation within regulated Life Sciences and Healthcare environments. In-depth knowledge of regulatory requirements, including GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11, is essential.

Proven experience with enterprise-level applications such as ERP, MRP, QMS, and LIMS. Demonstrated ability to define and execute end-to-end validation activities for IT projects and system updates. Familiarity with data migration, cloud validation, supplier assessments, AI/ML validation, and infrastructure qualification is highly valued.

Excellent written and oral communication skills are required, with the ability to engage effectively across all organizational levels. Strong problem-solving skills, adaptability to change, and the capacity to work effectively under pressure are key attributes. A Bachelor's degree in Engineering (BE/B.Tech) or any full-time graduation is required.