Senior Consultant - Business Consulting Risk - TMT - CNS - RISK - DIGITAL RISK - Bangalore

Computer System Validation (CSV) Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements). Create/review CSV deliverables like user requirements, system specifications, validation plans, qualification plans, SOPs, IQ/OQ/PQ, traceability matrices, design specs, and validation summary reports. Provide guidance and oversight of validation activities for projects involving GxP-relevant computer systems. Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle. Review and approve computer system validation work products, ensuring thoroughness of validation planning and progress toward timely completion of validation deliverables. Skills & Attributes for Success Experience in quality and compliance with hands-on validation experience on enterprise applications (LIMS, ERPs, LMS, RPA, CTMS, etc.). Experience in FDA-regulated environments with a good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation. Experience with validation/testing tools like HPALM, Azure DevOps (ADO), and other validation frameworks will be an added advantage. Experience in training validation resources will be an added advantage.