Project coordinator LIMS in Clinical & Preclinical DMPK/ADME institute - Implementation SQL*LIMS - Process analysis and process reengineering

- Configuration management - System validation co-coordinator - Life Cycle Documents (User Requirements, Functional Specs, Design Specs, Risk analysis, Testing plans, etc.) - Design and programming of interfaces to MS/ HPLC, Eliza - Programming of Oracle - PL/SQL Scripts enhancements of SQL*LIMS database

Manage process development and validation activities related to LIMS Pilot Implementation Project as the technical expert and lead. Organize and analyze user requirements, validation protocols & test scripts, generate Risk Assessment Document and Installation Documentation, configure and code in LabWare LIMS and coordinate user testing. Design and deliver software training material for varying levels of laboratory LIMS users. Performed informal and formal execution of test scripts for the validation of LabWare LIMS upgrade from version 4 to 5. Managed technical, process development and validation activities related to LIMS/Empower Integration Project. Developed System Requirements and Validation Protocols, write test scripts, revise Configuration Design Documents, generate Risk Assessment Documents and Tracibility Matrix, create Final Reports and coordinate release ensuring 21 CFR Part 11 compliance. Provided suggestions and support for users on LIMS related issues ensuring timely and efficient resolution. Specifications Administrator/Technical Writer/ELN Development Responsibilities: Supported QC Laboratory operations by managing the activities related to raw materials, intermediates, drug substances, and products through the administration of the Achiever EDMS Electronic Document Management System Facilitated the implementation of new or revised specifications by managing the QC portion of the Achiever document control process Supported the development of product/production material specifications that sustain and comply with manufacturing process/analytical method capabilities Interacted with manufacturing, purchasing, materials management, R&D,

and external customers and vendors to ensure the specifications are appropriate for the product/production material, and adhere to all regulatory guidelines Supported the revision of test methods by managing the Achiever Document Control process to completion Prepared, reviewed, and/or issued policies, guidance documents, and/or procedures (SOPs) designed to bring QC into sustainable compliance with cGMPs, corporate, domestic, and global regulatory requirements Monitored industry trends and recommended changes/revisions to systems and procedures as needed in order to maintain sustainable compliance Reviewed process validation protocols, reports, and technical agreements Provided analytical and technical support to internal customers/groups such as customer relations, quality assurance, quality control laboratories operations (chemistry and microbiology), manufacturing, validation, product improvement, and R&D Strong computer science skill sets. Project/Goal oriented with sound judgment and a common sense approach. Able to conceive, plan and, execute R&D, IT projects, interpret and present results. Demonstrated decision-making ability applying scientific principles and techniques to projects. Expertise in LIMS, ELN, Empower CDS, analytical method development, and instrumentation interfacing. Expertise in laboratory computer systems validation (IQ/OQ/PQ), gathering user requirements, SOPs, GAMP / SDLC / SILC validation documentation, CFR21 part 11). Project lead for VelQuest Electronic Laboratory Notebook (ELN) implementation. Expertise in software and method conversion/coding. Transformed user requirements into a complex, high quality finished product incorporating best practices and benchmarking. Subject matter expert (SME). Labware LIMS system administrator and SME. VelQuest Smartlab system administrator and SME Waters Empower system administrator and SME