RC-REGULATORY COMPLIANCE-Labware - BA-Senior

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 strong 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 client's 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).
• 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 5-8 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

Ideally, you’ll also have

• Information Security (ISO 27001) or Risk Management certifications
• LIMS adm