Devang Shah Email & Phone Number

Toronto, Canada Area

Toronto, Canada Area

- Hands on experience with LIMS and Empower system Implementation on multiple client sites.- IT system administrator for SQL LIMS, Empower systems, Waters LIMS, Nugensis, Agilent Chemstore, Chemstation & other Lab applications.- Provided day to day support for the labs & make sure all applications are functional at all times.- Participating in Annual Quality Reviews.- User access review.- Represent IT to HPFBI/FDA Audit.- Experienced with Six Sigma, 5S & Process… Show more - Hands on experience with LIMS and Empower system Implementation on multiple client sites.- IT system administrator for SQL LIMS, Empower systems, Waters LIMS, Nugensis, Agilent Chemstore, Chemstation & other Lab applications.- Provided day to day support for the labs & make sure all applications are functional at all times.- Participating in Annual Quality Reviews.- User access review.- Represent IT to HPFBI/FDA Audit.- Experienced with Six Sigma, 5S & Process improvements.- Basic understanding of networking principals (subnets, routing, switching).- Handled Multiple client sites & responsible to meet Company's SLA with client.- Working knowledge of antivirus and backup software * Understanding of database (ODBC) connectivity and basic SQL commands- Empower support:-• Computer support (Desk-side)• Software support• Basic instrument troubleshooting• User account administration• User Group management• User Type management• Annual imaging of LAC/e• Weekly rebooting of LAC/es, and as requested• Add / Remove Instruments as requested Show less

Ontario, Canada

- Install and Validate Waters Empower LACE as per Company's IOQ Protocol.- Developed and Review different IOQ Protocol for Empower and LIMS sytems.- Installed and Validate 3rd Party detector like QDA & CAD detector to work with Empower LACES.- Coordinate activities with vendor when needed- Lead LIMs and Empower COE.- Lead team for New/Modify LIMs reports in development, testing, validating & implementation.- Developed System securities, Job types, Audit Reasons and… Show more - Install and Validate Waters Empower LACE as per Company's IOQ Protocol.- Developed and Review different IOQ Protocol for Empower and LIMS sytems.- Installed and Validate 3rd Party detector like QDA & CAD detector to work with Empower LACES.- Coordinate activities with vendor when needed- Lead LIMs and Empower COE.- Lead team for New/Modify LIMs reports in development, testing, validating & implementation.- Developed System securities, Job types, Audit Reasons and Tested during Validation and make sure designed settings as per company’s requirements.- Tested Vendor’s custom reports in Validation as well as Production environment. Identified gaps between old system vs. new system and addressed Gaps.- Gathered user requirements for LIMS and EMPOWER system and custom reports. Communicated and Interpreted requirements with vendors for User Requirements.- Wrote system specifications, Functional specification and Executed and tested in validation and production environments. - Wrote Operational, User and Administrative Procedures for Laboratory Information Management System.- Developed System configuration guide and Training plans for different user groups.- Developed Sample life cycle, Custom Reports testing procedures, test plans for system performance and other system critical parameters in GMP-compliant validation documents.-Helped writing Internal, Operational & Performance Qualification Reports. Show less

Whitby, Ontario, Canada

- Involved in SQL*LIMS implementation of (Laboratory Information Management System), Accountable for Key Project deliverable.- Trained as a Administrator in SQL*LIMS. - Involved in creation of URS, Developed LIMS Report from scratch.- Designed FS, DS & Testing script of each LIMS reports.- Designed, Developed & Executed LIMS system PQ.- Led a team of Super User for LIMS Unit Acceptance Testing.- Worked closely with project Manager, understood and worked on the… Show more - Involved in SQL*LIMS implementation of (Laboratory Information Management System), Accountable for Key Project deliverable.- Trained as a Administrator in SQL*LIMS. - Involved in creation of URS, Developed LIMS Report from scratch.- Designed FS, DS & Testing script of each LIMS reports.- Designed, Developed & Executed LIMS system PQ.- Led a team of Super User for LIMS Unit Acceptance Testing.- Worked closely with project Manager, understood and worked on the project management principles. Experienced with Planning, Scheduling, Supervision (Lead Super users Team), project Control, Risk assessment & gap Analysis.- Involved in formulation development, helped less experience staff members in their trouble shooting activities- Troubleshoot technical/ Instrument problems during analytical development. Identify errors caused by calculation and formulas. Checking calculation formulas against United States Pharmacopeia /British Pharmacopeia or other client methods. Show less

Ontario, Canada

- Performed chemical and physical analysis on analytical samples in accordance with established procedures and is familiar with simple trouble-shooting techniques. - Developed and Analyze Assay, Related substances, Content uniformity, Hardness, Friability, Loss on Drying, Chiral purity, Uniformity of dosage units and Divisibility of feasibility, clinical and registration batches using Engineering principles. - Produced analytical work in accordance with the… Show more - Performed chemical and physical analysis on analytical samples in accordance with established procedures and is familiar with simple trouble-shooting techniques. - Developed and Analyze Assay, Related substances, Content uniformity, Hardness, Friability, Loss on Drying, Chiral purity, Uniformity of dosage units and Divisibility of feasibility, clinical and registration batches using Engineering principles. - Produced analytical work in accordance with the applicable SOPs, analytical monographs and observe all safety procedures- Working knowledge and basic understanding of the operation and use of electronic and computerized integrator- Produced analytical reports that are documented in accurate format and is responsible for the analytical integrity of all work performed Show less

Bachelor'S Degree, Engineering

Bachelor'S Degree, Engineering

Diploma, Project Management, A+