highlisted

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

EY·Hyderabad

Pay not stated5–8 yrsFull-time

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About the role

We’re looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our EY-Regulatory Compliance team. Gather and analyse business requirements related to LIMS functionality and enhancements. Stay up to date with new LIMS technologies, trends, and best practices.

What you'll do

  • Help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies
  • Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements
  • 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

What you need

  • 5–8 yrs of experience
  • Compliance
  • ERP
  • Documentation
  • SOP writing
  • GMP
  • GLP
  • Chartered Accountant or B.Tech or B.E.

Good to have

  • Chemistry
  • SAP
  • Instrumentation
  • Business analysis
  • Data structures
  • SQL

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