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

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 : 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. 

CSV (Computer System Validation) – ITRA

The opportunity

ITRA is one of the most important risks facing businesses today. Systems and processes are becoming increasingly interconnected and automated and many organizations are now reliant upon technology to drive business strategy and growth. Our clients are overwhelmingly turning to EY for help and guidance on how to protect their assets, minimize business disruption and improve security as they continue to exploit technology and the Internet of things.

As part of the team, you will be working on CSV, which provides our internal customers with a Technology recharge (bill) which is timely, defensible, and meaningful service-oriented and based on true cost and volume drivers. It is being used by technology and business managers globally to view their individual areas’ technology spend.

Vacancy for Roles

The current vacancy is only for the roles of Associate Consultants/ Consultants/ Senior Consultants. The role will be finalized based on experience of the candidate.

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, SAP, 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 in training validation resources will be an added advantage.

To qualify for the role you must have

• A graduate degree from a reputed University

• 3 - 13 years of overall CSV experience

• Hands on experience of 21 CFR/ CSV

Ideally you’ll also have

• Excellent written and verbal communication, interpersonal, networking, teaming and problem-solving skills

• Be highly flexible, adaptable, and creative.

• Initiative in keeping abreast of changing industry practices, analysis and design methods, tools and techniques and emerging technologies

• Willingness to work in different time-zones as required

What we look for

Highly motivated, you will be a good communicator with the ability to contribute confidently to technical security discussions with peers and management. You will be a team player who is not only looking to enhance their own career, but recognises the value in working well with others and the value of teamwork.

What working at EY offers

EY is committed to being an inclusive employer and we are happy to consider flexible working arrangements. We strive to achieve the right balance for our people, enabling us to deliver excellent client service whilst allowing you to build your career without sacrificing your personal priorities. While our client-facing professionals can be required to travel regularly, and at times be based at client sites, our flexible working arrangements can help you to achieve a lifestyle balance.

About EY

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 to make things better. So that whenever you join, however long you stay, the exceptional EY experience lasts a lifetime.

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

Join us in building a better working world. Apply now.

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 postivie energy, while being adaptable and creative in their approach. 

What we offer

With more than 200,000 clients, 300,000 people globally and 33,000 people in India, EY has become the strongest brand and the most attractive employer in our field, with market-leading growth over compete. Our people work side-by-side with market-leading entrepreneurs, game- changers, disruptors and visionaries. As an organisation, 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 whilst allowing our people to build their career 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 building a better working world. Apply now.