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

EY

5–8 yrs Hyderabad Full Time Hybrid (office + remote)
EY logo
Posted : today
Actively hiring

Job description

Join EY's Regulatory Compliance team as a Senior Configuration Analyst, specializing in LIMS implementations for the Life Sciences industry. You will be instrumental in shaping a growing service offering, helping clients meet their business needs with EY's established methodologies. This role demands proactive risk identification, high-quality deliverables, and strengthening client and internal relationships.

Responsibilities

Your core responsibilities will include gathering and analyzing laboratory and LIMS requirements, configuring LIMS platforms (LabWare, Benchling, STARLIMS) for end-to-end workflows, and designing master data, workflows, and business rules aligned with GxP and regulatory standards. You will develop integrations with enterprise systems, support validation activities (IQ/OQ/PQ), and troubleshoot system performance. The role also involves translating business and compliance requirements into digital lab solutions and ensuring data integrity, traceability, and adherence to regulations like 21 CFR Part 11 and Annex 11.

Qualifications

We are seeking individuals with 5-8 years of experience in LIMS implementations within Pharmaceutical or Life Sciences industries, preferably from Big 4 or multinational companies. A B.E./B.Tech in Computer Science, Life Sciences, Chemistry, or IT, or a Postgraduate degree in Science (Chemistry/Biochemistry) is required. Essential skills include a strong understanding of laboratory workflows, data integrity, LIMS platforms (LabWare, LabVantage, STARLIMS), system integration, SQL, and API integrations. Excellent communication, problem-solving, and stakeholder management abilities are crucial.

Essential Skills

LIMSLabWareSTARLIMSLabVantageGxP21 CFR Part 11ALCOA+Data IntegrityMaster Data ConfigurationSystem IntegrationSQLAPI IntegrationsStakeholder ManagementRegulatory ComplianceLaboratory WorkflowsValidationIQ/OQ/PQ

Good to Have

ISO 27001Risk ManagementLIMS Admin CertificationCertified Scrum MasterBenchlingSampleManagerERPELNMESDocumentumTrackWiseVeeva VaultValGenesisScriptingAutomation

Highlights

  • Actively hiring

More Details

RoleRC-REGULATORY COMPLIANCE-Lab Digitisation - CA-Labware-Senior
IndustryPharmaceuticals, Management Consulting
DepartmentInformation Technology, Engineering, Science, Compliance
Employment TypeFull Time, Hybrid (office + remote)

About the Company

EY Global Delivery Services ( EY GDS) logo

EY Global Delivery Services ( EY GDS)

Pharmaceuticals

RC-REGULATORY COMPLIANCE-Lab Digitisation - CA-Labware-Senior at EY | SkillMX | SkillMX