RC - REGULATORY COMPLIANCE - Lab Digitisation - CA - Labware - Staff

Location

Bengaluru

Other locations

Primary Location Only

Salary

Competitive

Date

Sep 25, 2026

Job description

Requisition ID

1745391

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all.

EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Staff – Labs – Configuration Analyst

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

We’re looking for Staff with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements.

Gather and analyse business requirements related to LIMS functionality and enhancements.

Configure and customize LIMS platforms (Preferably LabWare, Labvantage) to support end-to-end laboratory workflows including sample lifecycle management, testing, stability studies, and reporting.

Design and implement master data, workflows, and business rules (e.g., specifications, test methods, instruments, calculations) aligned with GxP requirements and regulatory standards.

Develop integrations and data interfaces between LIMS and enterprise systems (e.g., CDS, ELN, ERP, MES) using APIs, middleware, or flat-file exchanges to enable seamless data flow.

Support validation and compliance activities by preparing configuration documentation, executing IQ/OQ/PQ, and ensuring adherence to 21 CFR Part 11, ALCOA+ data integrity principles.

Troubleshoot and optimize system performance by resolving configuration issues, enhancing usability, and driving continuous improvement initiatives across laboratory operations.

Partner with clients to understand laboratory operations and translate business and compliance requirements into integrated digital lab solutions and their respective configurations

Drive requirements gathering, system configuration, data migration, and integrations across lab systems, instruments, and enterprise platforms

Ensure data integrity, traceability, and compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs

Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively.

Identify opportunities for automation and process improvement within laboratory operations using LIMS.

Drive and support LIMS enhancements and process improvements across global sites as required.

Master Data Design Configuration

Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets.

Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS.

Maintain data integrity, consistency, and version control across the system.

Implement changes and updates to LIMS master data in alignment with business and regulatory needs.

Collaborate with cross-functional teams to ensure accurate data migration and system integration.

Troubleshoot and resolve issues related to master data configuration and system functionality.

Work on optimizing data structures and database management within LIMS.

Configure and onboard new laboratory instruments, including both file-based instrument integrations and direct instrument connections.

Support Microbiology Method Execution processes through LIMS configuration and master data maintenance.

Application Support

Develop, customize, and implement LIMS applications to meet laboratory and business requirements.

Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms.

Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software.

Design and optimize databases for efficient storage and retrieval of laboratory data.

Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes.

Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime.

Skills and attributes for success

Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles.

Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards.

Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance.

Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations.

Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories.

Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms).

Knowledge of system integration with ERP, MES, or other enterprise applications.

Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS.

Hands-on experience in master data configuration within LIMS platforms.

Experience in system vali