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

Requisition Id: 1664949

As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that it’s your career and ‘It’s yours to build’ which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self.

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

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

• CSV (Computer System Validation), Equipment Qualification (CQV), Automation testers, Quality Assurance - ITRA The current vacancy is for the roles of Associate Consultants, Consultants, and Senior Consultants in the following domains (click on the link below to read JD) . The final role will be assigned based on the candidate’s interview performance and expertise.
• Computer System Validation (CSV)
• Equipment Qualification (CQV)
• Automation Testing
• Quality Assurance (QA) Key Responsibilities 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. Equipment Qualification (CQV)
• Perform equipment qualification (IQ/OQ/PQ) for laboratory and production equipment in a pharmaceutical setting.
• Ensure compliance with cGMP, FDA, and industry standards for equipment and utilities qualification.
• Prepare and review validation protocols, test scripts, and final reports.
• Work closely with engineering, quality, and operations teams to support equipment qualification activities.
• Troubleshoot equipment issues and recommend corrective actions.
• Maintain qualification documentation and ensure audit readiness. Skills & Attributes for Success
• Strong knowledge of commissioning, qualifications (FAT/SAT/DQ/IQ/OQ/PQ) and decommissioning activities.
• Hands-on process engineering and/or operational experience
• Prior knowledge of working on plants operated with an MES is preferable.
• Understanding of cGMP, GMP, FDA, EU Annex 11 and other regulatory compliance requirements.
• Ability to troubleshoot equipment issues and recommend corrective actions is an added advantage. Automation Testing
• Conduct automation testing, including functional, regression, and performance testing.
• Develop and execute test scripts and automation frameworks using Tosca.
• Strong understanding of how to identify, document, and manage test defects.
• Perform testing for Salesforce applications ensuring functionality and performance compliance.
• Conduct cross-browser and cross-platform testing using BrowserStack.
• Ensure compliance with regulatory requirements in automation testing. Skills & Attributes for Success
• Experience in test automation using Tosca.
• Strong hands-on experience in Salesforce testing.
• Proficiency in BrowserStack for cross-browser and cross-platform testing.
• Strong programming/scripting skills for test automation.
• Familiarity with AI-driven testing methodologies (preferred but not mandatory).
• Knowledge of regulatory requirements related to software testing in pharma environments is an added advantage. Quality Assurance (QA)
• Ensure compliance with regulatory requirements, including FDA, MHRA, EMA, and other global regulations.
• Maintain and improve Quality Management Systems (QMS) in pharmaceutical environments.
• Prepare for and manage regulatory audits and inspections, ensuring audit readiness.
• Develop, implement, and review SOPs related to quality assurance and compliance.
• Conduct internal audits and CAPA management to ensure compliance.
• Provide training and support on quality standards, regulatory requirements, and best practices. Skills & Attributes for Success
• Expertise in regulatory compliance and QMS implementation.
• Experience in conducting and managing audits (internal and external) and regulatory inspections.
• Strong understanding of FDA, MHRA, EMA, and other pharmaceutical compliance regulations.
• Ability to develop and maintain SOPs, CAPA management, and deviation handling.
• Experience in providing training on quality assurance standards and compliance best practices.
• Certified Quality Auditor (CQA) or similar professional certification is a plus.

Skills and attributes

To qualify for the role you must have
Qualification

• Bachelor of Science in Chemistry
• Bachelor of Technology in Computer Science
• Bachelor of Technology in Mechanical Engineering
• Bachelor of Business Administration
• Bachelor of Computer Applications

Experience

• A graduate degree from a reputed university. 3 - 16 years of overall CSV, QA, automation testing, or laboratory experience. Hands-on experience with 21 CFR/CSV regulations.
• Quality Assurance & Testing (3+ years)

What we look for

People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful, and able to sustain positive energy, while being adaptable and creative in their approach.

What we offer

Fuelled by the brilliance of our people, EY has emerged as the strongest brand and the most attractive employer in our field, with market-leading growth over competitors. Our people work side-by-side with market-leading entrepreneurs, game-changers, disruptors, and visionaries. As an organization, we are investing more time, technology, and money than ever before in skills and learning for our people. At EY, you will have a personalized Career Journey and also the chance to tap into the resources of our career frameworks to better know about your roles, skills, and opportunities.

EY is equally committed to being an inclusive employer, and we strive to achieve the right balance for our people—enabling us to deliver excellent client service while allowing our people to build their careers as well as focus on their wellbeing.

If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible.

Join us in shaping the future with confidence. Apply Now