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, 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 Dev Ops (ADO) etc. will be an added advantage. ? Experience in training validation resources will be an added advantage.

Skills and attributes
To qualify for the role you must have
Qualification

- Bachelor of Technology in Computer Science
- b pharmacy
- Bachelor of Computer Applications

Experience

- csv 2 to 13 years

What we look for
People with the ability to work in a team-oriented 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.

📌 Consultant - Business Consulting Risk - TMT - CNS - RISK - DIGITAL RISK - Mumbai (India)
🏢 EY
📍 India