Job Summary

EY- GDS Consulting - Enterprise Risk (ER) - Regulatory Compliance - Senior - Labs - BA

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 Senior 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.
- Analyse laboratory workflows and processes to recommend and implement LIMS solutions.
- Translate business needs into functional specifications and system configurations.
- Configure, test, and validate LIMS functionalities to meet business needs.
- Conduct impact analysis and risk assessments for LIMS changes and enhancements.
- Serve as a liaison between business users and technical teams to ensure effective communication and system alignment.
- Participate in business process mapping and workflow optimization to enhance LIMS utilization.
- Provide input on LIMS enhancements and new feature development to improve system performance.
- Assist in troubleshooting, identifying, and resolving LIMS-related issues.
- Conduct user training sessions and provide end-user support.
- 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.

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.

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.
- Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability.
- Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications.
- Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc.
- Stay up to date with new LIMS technologies, trends, and best practices.
- Ensure system security, access control,



and compliance with IT policies.
- Provide ongoing support and maintenance for LIMS applications.
- Engage in change management processes and drive adoption of new system functionalities.
- Work with vendors and third-party providers to Configure, implement upgrades and enhancements.
- Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines
- Maintain a robust client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the clients business.
- Review status updates and prepare management presentations.
- Actively contribute to improving operational efficiency on projects & internal initiatives.
- Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
- Contribute to performance feedback for staff
- Foster teamwork and a positive learning culture
- Understand and follow workplace policies and procedures
- Training and mentoring of project resources
- Cross skill and cross train the team members as per the business requirements

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).

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 RC-REGULATORY COMPLIANCE-Labware - BA-Senior (Hyderabad)
🏢 EY
📍 Hyderabad