EY Consulting is seeking a Senior Consultant specializing in Business Consulting Risk within the Technology, Media & Entertainment, and Telecommunications (TMT) sector, focusing on Digital Risk in Bangalore. This role is pivotal in helping TMT organizations navigate industry convergence, drive transformation, and achieve agile strategies for growth. You will contribute to creating exceptional employee and customer experiences, safeguarding data, brand, and reputation, while enabling value-generating M&A strategies.

As part of the CNS - RISK - DIGITAL RISK team, you will leverage people, technology, and innovation to solve strategic client problems. The focus is on identifying and managing risks to ensure long-term business success and resilience. The role involves working across key fields including Enterprise Risk, Technology Risk, and Financial Services Risk, with a specific emphasis on Computer System Validation (CSV) for Life Sciences clients.

Key responsibilities include performing assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. You will create and review critical CSV deliverables such as user requirements, validation plans, qualification plans, SOPs, IQ/OQ/PQ, and validation summary reports. Providing guidance and oversight for validation activities on GxP relevant computer systems is essential. You will collaborate closely with project team members to integrate quality and compliance throughout the system lifecycle and review/approve computer system validation work products.

To excel in this role, you must possess hands-on experience in Computer System Validation (CSV) with Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of FDA regulated environments and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with risk-based validation, is crucial. Experience with validation/testing tools such as HP ALM or Azure DevOps (ADO) is advantageous. The role requires a Bachelor of Technology in Computer Science or Pharmacy and 2 to 13 years of experience in CSV. We seek individuals with a collaborative approach, practical problem-solving skills, and an agile, curious, and creative mindset.