Neset Yucel

The project involved determining the necessary conditions for production areas during the factory construction phase; identifying the equipment, electrical lines, and data lines needed in the production rooms; determining and ordering the necessary stainless steel materials to ensure the areas meet GMP (Good Manufacturing Practices) requirements; and monitoring the setup of all production areas (granulation, tablet pressing, capsule filling, coating equipment, and blister and boxing line) and ensuring the execution of IQ, OQ, and PQ processes.

I also conducted capacity calculations and determined labor times for the products to be worked on in the area.

I ensured the writing of all necessary SOPs and instructions for the production department.

Since it was the first pharmaceutical production factory established in Azerbaijan, I ensured the training of local personnel (white-collar and blue-collar).

I prepared the secondary and primary areas for GMP audits, and we successfully completed the audits.

I manage the Liquid and Semi-Solid Production and Packaging departments, as well as the High Potent (Oncology) Production department. My responsibilities include monitoring the qualification and installation of new production equipment in these areas, writing URS (Universal Production System) documents for relevant equipment, setting up the High Potent (Oncology) production area, and managing the qualification of all equipment. This process also involves establishing necessary contacts with relevant departments to ensure progress, determining production quantities for new products based on equipment capacity, and defining the product equipment chain.

Responsibility for all solid dosage forms, as well as pellet production, pellet coating, capsule filling, and support pouch, liquid, semi-solid, liquid, and FDF packaging operations. Maintaining constant communication with relevant departments to ensure high-quality products are delivered to the market on time. Ensuring that daily/monthly production targets are met and providing a smooth production flow (physical, product documentation, GMP, HSE). Ensuring that monthly, quarterly, and annual financial targets are met and working towards improving financial targets. Organizing and supporting process validation activities, batch increase, launches, and product transfers.

During the relocation of the factory from Esenyurt to Çerkezköy, I was responsible for the transfer and validation of all products to the new factory (cleaning and process validations), the management and supervision of personnel in all departments (weighing, solid, solid packaging, liquid, liquid packaging, and subcontractor personnel), the installation and adaptation of the ITS system in the packaging department, and the exit of completed products from the SAP system. After the transfer processes were completed, I carried out improvement projects for existing products, visited the Italian site within the scope of the project, and exchanged ideas. I also monitored the production of the company's products planned to be produced in other factories and adapted the production processes to the existing factory. I was involved in very comprehensive tasks.

Solid Production: My job description includes monitoring wet-dry granulation and spraying processes (for tablets, capsules, and effervescent tablets), followed by tablet printing and coating processes, and resolving any issues that may arise at these stages. Additionally, I oversee the production protocol after production and provide production quantity confirmations on the SAP system. Preparing and revising relevant production protocols and creating the product tree and route on the SAP system are other tasks I perform.

In the hormone-based products department, I ensured that sterile liquid filling and packaging, as well as the production and packaging of solid and semi-solid products, were carried out under GMP conditions. I also played a role in media fill operations in the sterile area.

Organization of sterile filling and packaging processes in the cephalosporin sterile powder filling department. Monitoring of ointment production and packaging processes, weekly production planning, supervision and management of employees, writing and revising SOPs and instructions. Monitoring of production files.