Joseph Mercado Email & Phone Number

Guayama, Pr

Aibonito, Puerto Rico

Generated and executed validation/qualification documents for CSV application software / laboratoryequipment in the Chemical and Microbiological Area. CSV documents: Risk Assessments, Requirements,Design, and Traceability documents, Installation, Operational, and Performance test cases, Final Reports.Generated and executed deviations for CSV protocols.Generated, reviewed, and executed decommissioning documents.

Caguas, Puerto Rico

Carolina, Puerto Rico

Support of laboratory electronic documentation and data capture system integration project. Support of providing knowledge of analytical methods including information on analytical equipment, specifications, and parameters. Familiarization with laboratory data management system used for testing analysis, record retention, product disposition, and inventory. Participation of cross departmental meetings for training, troubleshooting, configuration, and development of electronic documentation and data acquisition system and LIMS with laboratory equipment.

Guaynabo, Puerto Rico

Humacao, Puerto Rico

Generated and executed qualification for CSV software in the Laboratory and Manufacturing Area including Quality Systems, Manufacturing Process, Utilities and PAT Data Management applications. Documentation of CSV and Data Integrity Risk Assessments, Requirements, Design, and Traceability documents, Installation, Operational, and Performance test cases, Final Report and Release Memos. Generated and executed deviations and amendments for CSV IOQ protocols.Reviewed and approved CSV lifecycle documentation including Risk Assessments, Requirements, Design, and Traceability documents, Installation, Operational, and Performance test cases, Reports and Release Memos.Organized and participated in Meetings with external vendors, SMEs and Project Managers to discuss project scope, for document generation, and for any situations found throughout the project. Participated in Activities to support the IT Compliance deliverables such as CAPA activities and Investigation analysis, decommissioning activities, CSV Periodic Reviews and Audit Trail Reviews (ATR).Developed the ATR Applicability Risk Assessment and schedule of ATR for CSV application software and equipment as part of the Data Integrity (DI) project. Identified gaps and provided recommendations and solutions related to IT metrics.Performed DI Risk Assessments using FMEA Risk Methodology for risk analysis, evaluated and addressed risk mitigation and reduction activities to comply with data integrity regulations, policies, and procedures. Evaluated and documented Data Flow Analysis, Technical, Procedural, and Audit Trail Analysis for Data Integrity Risk Assessments while utilizing Quality Risk Analysis.Developed and revised operational, administration, and troubleshooting procedures for the validation of systems, for compliance documentation.Worked with CSV systems and software application include synTQ PAT software, UV/VIS and FTIR intruments, Blender equipment, and Integration of software and equipment