Labware LIMS Consultant

About the Role

Tata Consultancy Services, a global leader in IT services and consulting for over five decades, is seeking an experienced Labware LIMS Consultant. This role is ideal for candidates skilled in Laboratory Information Management Systems, particularly within pharmaceutical and manufacturing environments. The position involves working onsite in major Indian cities including Bangalore, Hyderabad, Pune, Mumbai, Delhi, and Chennai.

Key Responsibilities

• Expertly manage and implement LabWare LIMS versions 7 and 8 configurations and customizations.
• Develop and review essential validation documentation such as URS, FRS, CS, DS, IQ, OQ, PQ, and test scripts to ensure compliance and functionality.
• Handle LIMS data management tasks including tables, folder management, static data creation, sample login templates, and configuration of products, analyses, and user accounts.
• Utilize multiple LIMS modules like EM and Dynamic EM, Stability, Lot tracking, Standards and Reagents, Batch processing, Instrument integration, and Investigation handling.
• Maintain adherence to regulatory frameworks including 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Conduct data migration, audit trail evaluation, periodic system assessments, and support documentation for changes, deviations, and CAPA processes.
• Lead end-user training sessions and facilitate audit preparation activities.
• Contribute strategic recommendations for LIMS lifecycle management and ongoing improvements.

Preferred Skills and Experience

• Comprehensive understanding of FDA cGMP/GLP and similar regulatory standards.
• Hands-on expertise in deploying, configuring, and customizing LabWare LIMS.
• Skilled in setting up sample plans, item codes, analyses, and product configurations tailored to specifications for raw materials, drug substances, and in-process materials.
• Proficient with advanced LIMS configurations such as Status Rules, Icon Rules, Info Rules, Event Triggers, User Programs, and User Dialogs.
• Experienced in performing administrative functions such as creating and modifying user accounts and roles, ensuring robust user support and service continuity.

Additional Information

This position demands 6 to 12 years of professional experience in Labware LIMS consultancy. Applicants must be graduates to be eligible for consideration.