Job Summary

The opportunity: Consultant-TMT-Business Consulting Risk-CNS - RISK - DIGITAL RISK - Mumbai

TMT:

Industry convergence offers TMT (Technology, Media & Entertainment, and Telecommunications) organizations the chance to evolve and transform, but it also presents challenges around competitiveness and delivering agile corporate strategies for growth. Content distributors are transforming into content producers, service providers are becoming tech companies, technology companies are the catalyst for dramatic change in every sector, and customers want the latest innovations now.

We help TMT companies create compelling employee and customer experiences, retaining skills and talent while achieving enterprise-wide operational excellence. We help them protect their data, brand and reputation. We also enable the pursuit of M&A; strategies that systematically create value, reduce risk and transform TMT companies into powerhouses that will lead the technology revolution of the future building a better working world for all.

CNS - RISK - digital RISK :

EY Consulting is building a better working world by transforming businesses through the power of people, technology and innovation. Our client-centric approach focuses on driving long-term value for our clients by solving their most strategic problems. EY Consulting is made up of three sub-service lines: Business Consulting (including Performance Improvement and Risk Consulting), Technology Consulting and People Advisory Services.





We help our clients in identifying and managing the interplay between upside and downside risk in order to make the long-term decisions to prevent risk and impact on their organization's ability to meet its future business strategy and objectives. The 3 key fields of play are :

- Enterprise Risk - helps clients identify and address key risk areas, while building the agility to respond quickly. The areas of focus include Enterprise risk and resilience, Internal audit, Compliance and Internal controls
- Technology Risk - helps clients to achieve sustainable growth by supporting their efforts to protect their business performance and by providing trusted communications on internal control and regulatory compliance to investors, management, regulators, customers and other stakeholders. EY teams accomplish this by assessing the technology risks that are introduced to businesses.
- Financial Services Risk - helps clients in the financial sector to identify, manage and monitor the risks in their business. It is done through a transformative and agile approach including process and procedures, risk, data modeling and analytics, reporting to stakeholders and third parties, business requirements (for software selection and IT implementation), analysis of assets and liabilities, and capital and liquidity management.





Your key responsibilities Technical Excellence
- 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 Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, 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, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables

Skills and attributes for success
- Experience in Quality and Compliance with hands-on computer system validation experience on Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS etc.)
- Experience in FDA regulated workplace with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
- Experience with validation/ testing tools like HPALM, Azure DevOps (ADO) etc. will be an added advantage.
- Experience in training validation resources will be an added advantage.

Qualifications
- Bachelor of Technology in Computer Science
- B Pharmacy
- Bachelor of Computer Applications

Experience
- CSV 2 to 13 years

📌 Consultant – Digital Risk (Mumbai)
🏢 EY
📍 Mumbai