Join our dynamic team as a Senior Consultant specializing in Computer System Validation (CSV) within the Life Sciences and Healthcare (LSHC) sector. This role is based in Hyderabad and offers a unique opportunity to drive innovation in enterprise technology.

We are seeking an experienced professional to lead and execute validation activities for GxP-regulated computerized systems. Your expertise will be crucial in ensuring regulatory compliance and supporting the growth of our clients' businesses.

You will be responsible for planning, executing, and maintaining validation processes for computerized systems in regulated environments. This includes developing validation strategies for agile and rapid delivery, defining and executing end-to-end validation activities for IT projects, and ensuring system validation needs are met through effective collaboration.

Key duties involve creating and reviewing critical validation deliverables such as Validation Plans, URS, FRS, and IQ/OQ/PQ test plans. You will also handle deviation management, conduct Root Cause Analysis (RCA), and manage change requests during the operational phase. Exposure to cloud validation, supplier assessments, and AI/ML validation will be advantageous.

A minimum of 8 years of experience in quality assurance and/or computerized system validation within the LSHC industry is essential. Proven knowledge of regulatory requirements like GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 is mandatory.

We are looking for candidates with at least 5 years of hands-on experience as a Computer System Validation Professional, including work with domain systems like ERP, MRP, QMS, and LIMS. Excellent communication, interpersonal, and collaboration skills are required to effectively engage with stakeholders at all organizational levels. Adaptability, self-confidence, and the ability to work under pressure are also key attributes.