RC - REGULATORY COMPLIANCE - Lab Digitisation - CA - Labware - Staff
EY
EY
Join EY's Regulatory Compliance team as a Configuration Analyst and play a pivotal role in digitizing laboratories within the Life Sciences industry. This is a prime opportunity to leverage your expertise in LIMS implementations and configurations, contributing to an expanding service offering within a leading global firm. You'll be instrumental in understanding client needs and delivering robust solutions that adhere to EY's rigorous methodologies, driving projects to successful completion with high-quality deliverables.
Your primary responsibilities will involve collaborating with stakeholders to gather and document LIMS requirements, configuring LIMS platforms (preferably LabWare or LabVantage) to support laboratory workflows, and designing master data, workflows, and business rules aligned with GxP standards. You will also develop integrations with enterprise systems, support validation activities, troubleshoot system performance, and ensure data integrity and compliance with regulatory standards like 21 CFR Part 11. Key tasks include driving requirements gathering, system configuration, data migration, and ensuring LIMS effectively supports laboratory practices and procedures.
To excel in this role, you need a B.E/B.Tech in Computer Science, Life Sciences, Chemistry, Information Technology, or a related field, or a Postgraduate degree in Science (preferably Chemistry/Biochemistry). A minimum of 2 years of experience with Big 4 or multinational regulatory compliance firms, or leading Life Sciences/Pharmaceutical industries, is required. Essential skills include a strong understanding of laboratory workflows, data integrity principles, LIMS software proficiency (LabWare, LabVantage), and familiarity with GxP, 21 CFR Part 11, and ALCOA+. Excellent communication, analytical, and stakeholder management abilities are also crucial.
EY Global Delivery Services ( EY GDS)
Pharmaceuticals