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.
- Configurations & Customizations
- 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 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 4-8 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 admin certification or Equivalent
- Certified Scrum Master (CSM) or Equivalent (Preferred but not required).
