Senior Consultant - Business Consulting Risk

Ernst & Young LLP ( EY India ); Bengaluru; On-site; INR 1,400,000 - 2,200,000; Full time

Job summary

EY Consulting in Bengaluru is seeking a Senior Consultant - TMT-Business Consulting Risk-CNS - RISK - DIGITAL RISK to help clients in the Life Sciences sector strengthen computer system validation, regulatory compliance, and risk management across enterprise applications.

You will assess systems, develop and review validation deliverables, and guide project teams to embed quality and compliance in the system lifecycle, working with cross-functional stakeholders to deliver accurate, audit-ready

Qualifications

• Bachelor of Technology in Computer Science.
• Experience in Quality and Compliance with hands-on computer system validation.
• Experience in FDA regulated environment with cGxP standards.
• Experience with validation/testing tools like HPALM and Azure DevOps.
• Experience with training validation resources.

Responsibilities

• Perform assessments of computer systems for Life Sciences clients in compliance with procedures and regulatory requirements.
• Create/review CSV deliverables such as user requirements, system specs, Validation Plans, IQ/OQ/PQ, Traceability matrices and validation reports.
• Provide guidance and oversight of validation activities for projects involving GxP computer systems.
• Collaborate with project teams to integrate quality and compliance into the system lifecycle.
• Review and approve validation work products and ensure timely completion of deliverables.

Skills

Quality & Compliance

GxP Validation

Validation Tools

Training Validation Resources

Education

Bachelor of Technology in Computer Science

Tools

HPALM

Azure DevOps

Job description

Senior Consultant - Business Consulting Risk - TMT - CNS - RISK - DIGITAL RISK - Bangalore (Requisition id: 1745134)

The opportunity

Senior 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

• 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 environment 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 with training validation resources will be an added advantage.

Qualification

Bachelor of Technology in Computer Science pharmacy Experience csv 2 to 13 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.

Experience Level Senior Level