kaliyan -

Led Thermo Fisher SampleManager LIMS 21.1 implementation, reducing manual lab errors by 40% and improving data traceability. Managed AWS-based cloud infrastructure with 99.9% uptime, ensuring full GxP and GMP compliance. Integrated MODA-EM and FDC systems for real-time environmental monitoring compliant with FDA and EMA regulations. Accelerated CSV lifecycle using GAMP 5 principles, improving audit readiness and cutting validation time. Oversaw rollout of LabSolutions CDS, spectrophotometer systems, and Microsoft D365 (SCM, inventory, quality, manufacturing). Developed automation workflows and analytics using SAS and Python, optimizing MS&T and QC lab performance. Defined IT/OT segregation frameworks aligned with GAMP 1–5, driving digital transformation and data integrity. Served as ServiceNow SME, managing GxP change control, CAPA, and compliance activities across the lab ecosystem.

Responsible for all Validation, Qualification, Calibration, and Engineering activities of the project. Preparation, Execution, and training of Site QA, Validation, Engineering and Production department personnel for URS, DQ, IQ, OQ, and PQ of New equipment / Instrument Preparation, Review, Training, and execution of all engineering-related SOP’s and Documentation of the Engineering Department according to EU, MHRA, and FDA requirements. Performing Impact assessment for identification of Qualification and validation requirements of Equipment, Instruments & amp; utilities Preparation/review of master validation plan in regard to facility, equipment, process, cleaning, and utilities Identification, coordination, and execution of validation and Qualification needs as per cGMP, Regulatory and VMP requirements. Co-ordination with engineering and projects department for preparation and review of new and existing project plans, drawings and layouts. Performing Quality Risk Assessment of Equipment, Utilities, Instruments, Facility, and Process according to ICH Q9 guidelines • Computer Systems Validation & Qualification (Software/Instrument/Equipment/Interface) • Various System including, SAP PP-QM, MM, EHS and PIPO, Salesforce CRM, Veeva Quality Docs, Veeva Submission, Veeva eTMF, MES, MasterControl and Trackwise • SampleManager LIMS, ELN, LES-IM, and Clinical Safety System and Other ERPs System • Quality Management Systems (QMS) • SDLC (Waterfall; V-model; Agile; Risk-Based Rapid Development) • 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 • ISO/IEC/IEEE Software Testing Standards • Medical Devices (ISO 13485) • IEC 62304 Medical Device Software Life Cycle • ISO 14971 Medical Device Risk Management • FDA 21 CFR 820 Quality System Regulation • Quality Systems Audit & Support

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.

Empower CDS Training related support personnel on L1 and L2 support activities. Documentation of Working Instructions and Standard Operating procedures related to Empower CDS support. Familiarization of personnel with Empower personal, workgroup, and enterprise environments along with steps for their installation, troubleshooting and instrument connectivity. Perform the Acquisition Machines / LACE re-build and communicate with other support teams like Database, Network and Server Ops team and complete the pre requisites for the deployment. Strong skill set for chromatography Instrument error troubleshooting, which include Chromatography Data such as processing data, reporting data etc. Troubleshooting for method set in which instrument method, processing method and reporting method in order to perform the CDS system working without any error. Troubleshooting for Data acquisition related error such as instrument and LACE connectivity issue, instrument module configuration issue etc. NuGenesis SDMS Experienced on Instrument Interference with Empower CDS to NuGenesis SDMS 8.0 database, example UPLC or HPLC and LCMS configured Empower 3 FR2 with NuGenesis SDMS 8.0. Configuring File Capture Templates Creating active scan lines Deactivating scan lines Configuring Print Capture Templates o Creating active scan lines Deactivating scan lines Configuration of application security policies Configuration of application views Review and update of vendor data adapters Review and update of application software Technical proficiencies in network & system security, backup & restore management, disaster recovery planning, data integrity \​ recovery, contingency planning, risk assessment. Involving regular activity such as user account creation, restoration of instrument data, setup of data capture agent server, configuration of a site in SDMS, problem reporting, backup and Archival process for NuGenesis SDMS.

LAC/E and client and instrument connectivity through various modules like 8-Port Equinox cable, Avocent box, Ethernet protocols etc Installed and verified Instrument control frame work (ICF) and Instrument control software (ICS) in Empower versions. Instrument validation for A7890B GC, A1000 and Acquity UPLC systems. Configured LC Systems and GC Systems with Empower 2, Empower 3 for qualification. Use and maintenance of Analytical instruments like UPC2, UPLC, HPLC, LC-MS, GC-MS instruments, Method development, Software compatibility testing on UNIFI/ Empower software/ MassLynx (CDS) Worked and implemented Empower 3 FR1 and FR2 upgrade project Preparing and testing of Empower CDS systems Technical installation plans