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

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 validation, testing, and documentation. 
• Exposure to Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in pharmaceutical organization
• Understanding of relational databases and SQL queries. 
• Experience with scripting or automation tools for LIMS is a plus. 
• Understanding of API integrations, web services, and middleware solutions for LIMS. 
• Ability to troubleshoot system and data issues efficiently. 
• Strong problem-solving and analytical skills. 
• Excellent communication and stakeholder management abilities. 
• Ability to work independently and as part of a cross-functional team. 
• Strong attention to detail and commitment to data integrity. 
• Adaptability to dynamic business and regulatory environments. 
• Demonstrated track record in project management, governance, and reporting
• Exposure to Data Integrity requirements and other applicable regulations
• Knowledge of Incident Management, Change Management.
• Prior experience of supporting Audits / Inspections

To qualify for the role, you must have

 

• B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 2+ years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries.
• Good interpersonal skills; Good written, oral and presentation skills
• Consulting or client‑facing experience preferred.
• Excellent communication, documentation, and stakeholder management skills.

Ideally, you’ll also have

 

• Information Security (ISO 27001) or Risk Management certifications
• LIMS admin certification or Equivalent
• Certified Scrum Master (CSM) or Equivalent (Preferred but not required).

What we look for

 

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consult