Mount Pleasant, South Carolina, United States
I am working for 4 years in Sanovel as a Validation Specialist. At this time, I am also working as Quality Assurance Specialist for 3 years in biotechnology and inhaler departments that will be established in Arven Kırklareli Site.
My responsibilities are in Sanovel; • Process Validation: To validate products in solid, liquid, sterile and cephalosporin departments. • Cleaning Validation: To validate equipments in solid, liquid, sterile and cephalosporin departments. • Aseptic Filling Validation: To validate media solution in sterile department. • HVAC and Water System Qualifications: To prepare performance qualification protocols, revalidation protocols, organize the sampling plan and report the results. • Risk Analysis: To write SOP that is FMEA method and to implement the SOP all around the factory risks. • Internal Audits: To audit GMP and ISO requirements in the departments. My responsibilities are in Arven; • Biotechnology Process and Cleaning Validations: To validate products and equipments in biotechnology department. • Inhaler Process and Cleaning Validations: To validate products and equipments in inhaler department. • Change Control and Complaints: • Aseptic Filling Validation: To validate media solution in sterile department. • HVAC and Water System Qualifications: To prepare performance qualification protocols, revalidation protocols, organize the sampling plan and report the results. • Control of Quality Control Documents (Stability, Raw Material, Product Analysis Report, Specifications and Methods, Analytical Method Validation, Holding Time Reports, General Test Methods) • Risk Analysis: To write SOP that is FMEA method and to implement the SOP all around the factory risks. • SOP: To write all SOP’s for Arven facility. • Internal and External Audits: To audit GMP and ISO requirements in the departments. I also contributed to General Electrics audit as head auditor for the biotechnology purification column packing material.