Senior TrackWise Consultant

1w1 week ago

Bengaluru, IN · Full-time · INR 2,500,000 – INR 4,000,000

About this role

At EY, join diverse teams in a globally connected powerhouse to shape your future and build a better working world. As part of the EY-ER-Regulatory Compliance team, deliver TrackWise Digital Quality Management solutions for Life Sciences clients in GxP-regulated environments. This senior role supports design, configuration, and implementation of compliant quality processes.

Responsible for end-to-end TrackWise Digital implementations, gather requirements and design solutions with client business, IT, and quality stakeholders. Configure systems, conduct demos, perform testing including IQ/OQ/PQ, and develop GxP documentation. Ensure high-quality delivery aligned with regulatory standards in agile project teams.

Actively establish and strengthen internal and external relationships while driving projects to completion. Proactively identify risks for clients and EY senior management. Lead internal initiatives for operational efficiency within the Regulatory Compliance team.

This opportunity enables contribution to impactful quality transformation initiatives. Work in agile delivery models supporting testing, defect resolution, and continuous improvement. Advance career delivering scalable solutions for regulated Life Sciences environments.

Requirements

Strong hands-on experience with TrackWise Digital
Solid understanding of quality and validation requirements
Experience supporting TrackWise implementations in GxP-regulated environments
Proficiency in requirements gathering, solution design, and configuration
Knowledge of validation activities including IQ/OQ/PQ
Familiarity with agile project-based delivery models
Ability to develop GxP-compliant documentation
Experience conducting system demos and user acceptance testing

Responsibilities

Collaborate with client business and IT stakeholders to understand business requirements and translate them into clear user stories
Develop functional specifications and technical designs aligned to defined requirements
Configure, build, and deploy TrackWise Digital solutions based on approved technical designs
Conduct system demos and playback sessions with client business and IT teams
Perform system configuration testing, support code reviews, and manage merges
Support creation, execution, and defect resolution for User Acceptance Testing (UAT) and validation testing (IQ/OQ/PQ)
Prepare, review, and maintain GxP-compliant documentation, including functional specifications, configuration documents, and validation artifacts
Ensure solution design and delivery adhere to quality and regulatory requirements in regulated Life Sciences