Gergana Todorova Bezhanska

• Development, management, monitoring and maintenance of GxP relevant processes and procedures ;
• Vendor management and qualification process / TPRM ;
• Management of deviations, CAPA management, Change management, Complaint management, Quality risk management/ risk assessment and other elements of the Quality System;
• Management of inspection readiness activities, and support of client audits and inspections;
• Organization and performing GxP training and provision of work guidance regarding GxP Requirements;
• Leadership and/or participation in contractor/supplier audits;
• Compliance Committee QA's Support;
• IT projects QA's support;
• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
• Developed strong communication and organizational skills through working on group projects.
• Demonstrated creativity and resourcefulness through the development of innovative solutions.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
• Vendor qualification / Requalification process - 150 - 180 processed Vendors per year ;
• NC and CAPA - 140 process per e-year;
• Involvment to 3 IT projects per year

 Ensures quality and compliance of the clinical trials,conducted with respect to Standard Operating Procedures, applicable regulatory requirements (e.g.FDA, EU, ICH & country specific, and current industry standards and practices);
 Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, and Quality Audits;
 Non-conformances processing / quality improvements using risk-based methodology.
 Staff training;
 routine and non-routine quality assurance audits
 QA review of SD templates, SOPs, training materials; and other clinical trial specific documents

• Ensuring GMP and quality considerations are included in the decision making processes.
• Ensuring standards and define key processes and systems for Quality Affairs.
• Recruit and training of the key people so as to run an efficient GMP focused quality organization.
• Ensuring that the company and the Quality Assurance are continually striving for improvements and keeping abreast of the requirements and the latest trends in GMP, and to provide adequate training to meet those needs.
• Ensuring that the preparation and approval of Standard Operating Procedures (SOPs) for activities related to quality is done.
• Ensuring that the regular and timely updating of all documents related to quality is completed.
• Ensuring that all required tests are conducted in compliance with their approved specifications.
• Ensuring that calibration and validation of equipment, systems, utilities and methods used by "Quality Control" are in compliance with internal policies.
• Ensuring that all activities relating to the Quality Assurance are carried out and documented in full compliance with the approved written procedures and that these instructions adequately reflect the state of current GMP.
• Organizing, preparing and coordinating CAPA / Change control / Risk Assessment / Supplier audits / Selfinspection / Process Validation
• Updating and maintaining the Quality Manual describing the Quality Management System including a description of the Pharmaceutical Quality System processes in scope of the QMS.
• Organizing, preparing and coordinating regular Quality Management reviews.
• Internal Audit conduction.
• Preparation for Inspections.
• Proper delegation of tasks in the division.
• Providing knowledge and observing of the company values through his/her work and behavior within the work and relationship with the employees

• Managing supplier homologation process: questionnaires, visits, action plans follow up, capability studies, PQC in the supplier facilities.
• Definining the IQC plans in the SAP system together with the Quality manager.
• Managing the NC related to raw materials:
• Opening NC in the SAP; managing of the red area, communication with the suppliers in coordination with the procurement team, derogations, and following up the actions with the suppliers.
• Leading the annual supplier audit program and the supplier improvement initiatives.
• Issuing periodical reports about the supplier performance – action plans from visits, improvement plans.

• Oversaw daily operations of a busy office environment, ensuring tasks were completed efficiently and accurately.
• Conducted regular reviews of operations and identified areas for improvement.
• Frequently inspected production area to verify proper equipment operation.
• Optimized supply chain management, resulting in reduced delivery times and increased inventory accuracy.
• Developed effective improvement plans in alignment with goals and specifications.

• Organizing and managing the Incoming QC inspectors to perform the IQC plans defined, managing the records and spec’s, golden samples from the customers;
• Organizing and managing the Production QC inspectors to perform the PQC plans defined;
• Analyzing and measuring the processes, solving the issues and conducting the necessary training to the shift and line leaders regarding Quality
• Managing all the records and retained samples; managing the non-conformities related to finish or semi finish products;
• Following up blocked materials and report weekly; managing the destruction or collection of the material;
• Issue periodical reports about processes performance (NC, Qualitative/ Quantitative test results, Scrap, and KPI in general);
• Suppliers audits.

• Conducted detailed root cause analyses following any non-conformance events, leading to swift identification and mitigation of potential risks.
• Assessed products or services to evaluate conformance with quality standards.
• Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
• Implemented process improvements to increase productivity in quality assurance operations.

• Organizing, preparing and coordinating
- IQ, OQ, PQ of equipment and systems for 6 different types of Manufacturing Facilities;
- Process validation : Gel. oitments / Infussion solutions / Syrups / Capsules - hard gelatin , soft jelatin capsules / Almagel solution
• Taking participation in activities related with :
- Technological transfer : 3 - 4 per year
• Self-inspections implementation : 5 - 10 pper year
• Preparation and filling in MQS (Monthly Quality Statistic, Key Performance Indicators) and QQR (Quarterly Quality Reports),
• Site master Files preparation - 6 per year

• Itroduction and observance of the pharmaceutical GMP principles;
• Self-inspections implementation;
• Basic GMP training;
• Introduction of standard Operating Procedures, Manufacturing Regulations
• Site master Files preparation;
• Participation in the Change Control system etc.
• Oversaw daily operations of a busy office environment, ensuring tasks were completed efficiently and accurately.
• Conducted regular reviews of operations and identified areas for improvement.