kaliyana sundaram

Led SampleManager LIMS 21.1 deployment, reducing errors 90% and improving traceability. Managed AWS cloud with 99.9% uptime for GxP compliance. Integrated MODA-EM & FDC for real-time FDA/EMA monitoring. Streamlined CSV lifecycle via GAMP 5, boosting audit readiness. Delivered LabSolutions CDS & D365 rollouts, built lab automation, and acted as ServiceNow SME driving digital lab transformation. Defined IT/OT segregation frameworks aligned with GAMP 1–5, driving digital transformation and data integrity.

• SampleManager LIMS, ELN, LES-IM, ERP, MES, eTMF CSV • Quality Management Systems (QMS) • SDLC Risk-Based FMEA • cGxP (GLP/GCP/GMP), Good Documentation Practice (GDP) • GAMP Guidelines applicable to CSV • 21 CFR Part 11 Electronic Records; Electronic Signatures • EU Annex 11 Computerized Systems • Medical Devices (ISO 13485) Experienced URS, DQ, IQ, OQ, PQ, and SOP update, and cGMP standards. master validation plan preparation, risk assessment (ICH Q9), and CSV per GAMP, 21 CFR Part 11, and ISO standards.

Lab Automation and extensive experience in Empower CDS 2 & 3, NuGenesis SDMS v7.1, LabWare LIMS v6, and other lab applications such as Chromeleon, Lonza MODA, etc. Lab Automation and extensive experience in Empower CDS 2 & 3, NuGenesis SDMS v7.1, LabWare LIMS v6, and other lab applications such as Chromeleon, Lonza MODA, etc. Expert in validation, qualification, calibration & engineering per EU, MHRA, FDA, and cGMP. Skilled in CSV, risk assessment, CAPA, and QMS using SAP, Veeva, and TrackWise.

An accomplishment-driven professional offering over 7 years of work experience and gained domain expertise in Life Sciences Industry (Pharmacovigilance, Manufacturing, & R&D) -Worked towards the adherence to FDA and EU regulations; currently working as an IT Quality Consultant for one of the top US Clients • Superior knowledge of FDA 21 CFR Part 11 Electronic Records and Electronic Signatures and Data integrity remediation -