• Quality management of critical systems (HVAC, WFI, OFA, etc.) and engineering equipment.• Participates in quality system actions (Change control, CAPA, etc.) Supports product and process deviations process, including risk assessments, PFMEA, root cause investigations, and preventive/corrective actions.• Supports external audits such as FDA, and IMOH, and leads internal audits for different departments.• Experienced in writing\approving procedures, documents, protocols, reports… Show more • Quality management of critical systems (HVAC, WFI, OFA, etc.) and engineering equipment.• Participates in quality system actions (Change control, CAPA, etc.) Supports product and process deviations process, including risk assessments, PFMEA, root cause investigations, and preventive/corrective actions.• Supports external audits such as FDA, and IMOH, and leads internal audits for different departments.• Experienced in writing\approving procedures, documents, protocols, reports, CCs, drawings, validation documentation, and proposals for change to production methods and test methods.• Actively participates in teams introducing new products \ processes to the facility. Defines the process controls and quality standards for new products and processes.• Experienced in validation-related documentation such as IQ, OQ, PQ, CSV, URS, etc.• Experienced in Maintenance activities such as preventive work, calibration, etc. Show less

• Provides comprehensive support and compliance for manufacturing-related processes from various quality aspects: industry and process excellence standards in routine quality operations, good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO-9001).• Leads and participates in continuous improvement projects to implement change within Operations by performing process reviews, and identifying steps critical to quality… Show more • Provides comprehensive support and compliance for manufacturing-related processes from various quality aspects: industry and process excellence standards in routine quality operations, good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO-9001).• Leads and participates in continuous improvement projects to implement change within Operations by performing process reviews, and identifying steps critical to quality. • Experienced in writing\approving procedures, documents, protocols, reports, CCs, drawings, validation documentation, and proposals for change to production methods and test methods.• Actively participates in teams introducing new products \ processes to the facility. Defines the process controls and quality standards for new products and processes.• Supports Supplier change notification process from SC quality perspective. • Experienced in validation-related documentation such as IQ, OQ, PQ, CSV, and URS.• Qualified for a new storage facility• Imported biological temperature-sensitive release process (Such as Plasma, Cryo, Albumin, etc.)• Provided GMP & GDP training for our external Warehouses (Globus Nehot Hovav, KarPri etc.)• QA ERP main liaison – has status change privileges, inventory control, BOM maintenance, new part numbers, material classification, MRB etc. Show less

• Performed Batch file review, maintained electronic batch records in the relevant system (e-LIMS), Approved Work Plan for the production department (planning), supervised material control to production.• Contributed to Cost Improvement Processes