Gergana Bezhanska's Linkedin Analytics

Experienced Quality Assurance Subject Matter Expert (SME) with over 21 years of successful career progression in the pharmaceutical industry. Proficient in leading expert teams, and organizational management across various sectors including Manufacturing, Clinical Trials, and Pharmacovigilance / QMC. Demonstrated expertise in Quality Management Systems (QMS) encompassing process development, implementation, and continuous improvement. Skilled in achieving GMP Certification, ISO 9001, and ISO 27001 Certification. Proficient with regulatory frameworks including HIPAA, 21 CFR Part 11, ICH R6, and GVP Module VI. Proven track record in SOP creation, personnel training, and effective management of Change Control, Non-Conformance (NC), and Corrective and Preventive Action (CAPA) processes, Audit / inspections, Training, Vendor management and Qualification. Experienced in conducting Risk Assessments utilizing methodologies such as Failure Mode and Effects Analysis (FMEA), Fishbone Analysis, and 5 Why + 5 How approach. Proficient in Value Stream Mapping to optimize processes, Vendor Management, and Qualification, as well as conducting Audits and inspections to ensure compliance with regulatory standards. Extensive experience as a GxP Senior Manager (covering GMP, GCP, GVP, QMC, ISO 9001/27001, and 17025) adept at leading global, dispersed teams in remote settings.