Edith Salas Gonzalez

Validation Technical

BEPC Professional Consulting

( Johnson & Johnson )

Validation package (OQ, IQ, PQ, PVE, CSV-E Validation)

• Protocol and Report
• Documentation upload in Windchill system (CN, CR)
• Document approvals
• Equipment registration in EHS
• Equipment registration in PM (Preventive Maintenance)
• Maintenance plan
• Equipment fault codes
• FMECA Equipment category classification
• Equipment calibration (External, Internal) Manufacturing

Manufacturing

• Engineering study of category 5 and 3 equipment
• Validation Assessment
• Compliance Analysis
• Execution and drafting of OQ, PQ, IQ, IQF
• Validation of category 3 and 5 equipment
• MLA Introduction of new equipment to the plant
• External quotation service
• Flow Diagram
• Update of Drawings (Shape Master)
• Update of work instructions
• Windchill System

BEPC Professional Consulting

( Johnson & Johnson Project EUMDR Ethicon)

• BOM Forms
• From To
• Route Sheets
• Windchill System ( Change Notice, Change Request)
• Validations Test Method Validation
• Confirmation Run Protocols Execute
• Software Validation Protocols Execute
• Execute Validations in Manufacturing
• Interpretation of Drawings
• Data Collection ( Minitab Software)
• Update documents the Manufacturing

BDPS - BD Production System is adapting to a new production system. Participation in TMS, CSD with activities in the implementation of training lines, improving the reduction of downtime and waste, and enhancing production metrics.

• Certification in TWI (Job Instruction Instructor Course)
• Zero Losses, waste control with greater contribution in the plant.
• Action plans to improve results in production lines.
• Active auditor in the 5S program.
• Design of work standards
• Execution of the Project Charter
• Capacity Study
• Wrap-up in production lines

Continuous Improvement Technician

Support the planning, design, and execution of continuous improvement projects, develop improvement ideas, and drive project execution. Time observations, machine capacity, identification of non-value-added activities. Identification and redesign of stations to eliminate ergonomic, safety, and process waste risks.

• Work area distribution
• Create visual aids
• Yamazumi charts, VA and N/VA charts
• Time studies
• Design and implementation of stations
• Implementation of CR’s in the Master Control program
• Completion and filling of forms for the validation process of new projects
• CAPA actions and closures
• 5S audits
• Process Map interpretation
• Execution of the DMAIC Shark project
• Waste analysis
• Workstation manufacturing procedures