Senior Consultant -Business Consulting Risk -TMT -CNS -Digital Risk -

We are looking for a highly motivated and experienced Senior Consultant to join our team in the Technology, Media & Entertainment (TMT) sector. The ideal candidate will have 3-13 years of experience in Computer System Validation (CSV) with hands-on experience in enterprise applications. ### Roles and Responsibility Perform assessments of computer systems and processes for Life Sciences clients. Create and review CSV deliverables including user requirements, system specifications, validation plans, qualification plans, SOPs, IQ/OQ/PQ, traceability matrices, design specs, and validation summary reports. Provide guidance and oversight on validation activities for projects involving GxP relevant computer systems. Collaborate with project team members to integrate quality and compliance into the system lifecycle. Review and approve computer system validation work products, ensuring thoroughness of validation planning and progress towards timely completion of validation deliverables. Work closely with internal customers to provide timely, defensible, and meaningful service-oriented solutions based on true cost and volume drivers. ### Job Requirements A graduate degree from a reputed university is required. 3-13 years of overall CSV experience. Hands-on experience with 21 CFR/CSV. Excellent written and verbal communication, interpersonal, networking, teaming, and problem-solving skills are essential. Be highly flexible, adaptable, and creative. Demonstrate initiative in staying updated on industry practices, analysis, design methods, tools, and emerging technologies. Willingness to work in different time-zones as needed. Experience in Quality and Compliance with hands-on computer system validation experience on Enterprise Applications (LIMS, ERPs, LMS, RPA, SAP, CTMS, etc.). Experience in FDA regulated environments with a good understanding of cGxP standards and Risk-based validation. Experience with validation/testing tools like HPALM, Azure DevOps (ADO), etc., is an added advantage. Experience in training validation resources is beneficial.