Business Technology Analyst, Carolina and Guayama Puerto Rico

Luis A. Jiménez Silva Tel. (787) - 653-6759 Home or Mobile 787-662-5229 E-Mail: luisjimenez0710@yahoo.com Skype ID: luis_jimenez_silva111 OBJECTIVE: I am seeking a challenging and opportunity position in Quality System Management related with Computer System Validation applicable to Information Technology, Laboratory and Manufacturing Operations . My background is in Biopharmaceutical industry. Summary: - Support Information to Management and Users in the organization on how to use various types of Software efficiently and effectively in fulfilling business objectives. This includes Labware LIMS, Empower, OpenLab, Trackwise, Isotrain, GxPharma, Minitab, MES and SAP-QM. Primary responsibilities include Project Management, Change Management, Validation Derivable, Define Technical Design, Business Requirements, Workflow, Revision, Upgrade, New Release, Improvement, Implementation, Configuration, Compliance, Maintenance and Enhancement the Quality System Operations. - Project Implementation establishes the Business Rules and Validation Requirements for Business Operation. In this application evaluate strategy of Business Requirements and Technical Design for Validation System. Coordinate the activities of team members (about 10-15 members) for Validation, Configuration, SOP Evaluation, and Training Module Certifications. Create the following documents in order to Define Validation Requirements as: Workflow As Is, Workflow To Be, Technical Design, SCO, Change Control, Project Plan, Validation Plan, Training Plan, SOP Plan, Impact Assessment, Traceability Matrix, Master Data Load Summary, IQ-OQ-PQ Summary, Test Scripts executions, Validation and Change Control Closure activities. -Development of computer software validation efforts CFR 21, part 11 and test codes, writes and /or executes Test scripts. Assist in the training of users, writing and perform training modules along with technical support for user and managers questions. Provide the support to IT Core Team, Manufacturing Process and Laboratory System Operations. Represent Subject Matter Expert and provide support to External Site Operation as NJ, NY, PA, Guayama-PR, Carolina-PR - Experience with LIMS configuration for Analysis and Product Specification for Raw Material, Intermediate, Final Product, Stability, Retain, Complaint, Sample and Lot Manager, Cleaning and Manufacturing validation samples. - LIMS Instrument Configuration is applicable to HPLC, GC, Dissolution Apparatus, Balance, Thermometer, Caliper, Column, Oven, Karl Fisher, IR Spectrophotometer, Water Bath, Shaker, Zebra Printers and others. -LIMS Standard and Reagents Configuration are applicable to Purchased and Home Prepared Solutions. -LIMS Interface configuration experiences with Empower, Balance, Caliper, PH Meter, Printers, SAP QM, OpenLab, Crystal Report, Investigation and LabStation. -LIMS configuration for Crystal Report is applicable to Store Query, Barcode Sample Labels, COA, Product Status, Test summary, Stability Report, Product History, Instrument due date calibration, Sample expire. -LIMS Configuration for Worksheet, QC Samples and ELN. -Experiences with Charting and Minitab to integrate Control Chart, Cpk, Histogram, Pareto, Regression and Trends. -Experiences with Data Migration Objects: Development, QA and Production Environments. -Experiences with review and approve analytical test report. Assure laboratory personnel follow proper testing standard procedure, GMP’S, GLP’S and Safety precaution. Perform and evaluated laboratory investigation report OOS, Product Disposition and assure corrective action to prevent recurrences. Evaluated Trend Analysis, Metrics, Charting, Annual Product Review and Compliance Audit Inspection. -Experiences with Laboratory Equipment qualification applicable to IQ, OQ and PQ. -Experiences with Manufacturing and Process Improvements related with MES, Equipment Qualification, Process Capability, Trends, Alert limits, Specifications and Process Excellence of DMAIC with Six Sigma evaluation.

Application Support

Caguas, PR