• Leading to formulation development team for new pipeline projects• Subject Matter Expert (SME) at formulation development and production issues• Optimization of products with various problems such as inappropriate lyophilization cycle, stability, homogeneity, capping, sticking, dissolution etc.• Line extension (adding new dose or dosage form) of some commercial products • Technology transfer of first commercial products into new small scale solid production area from the… Show more • Leading to formulation development team for new pipeline projects• Subject Matter Expert (SME) at formulation development and production issues• Optimization of products with various problems such as inappropriate lyophilization cycle, stability, homogeneity, capping, sticking, dissolution etc.• Line extension (adding new dose or dosage form) of some commercial products • Technology transfer of first commercial products into new small scale solid production area from the existing production area • Technology transfer support of products into our site from CMO site• Support for investigation and troubleshooting of commercial production deviations by performing lab trials, if required• Responding of authority deficiencies related with pharmaceutical development by performing lab. trials, if necessary• Technical evaluation, choosing and purchasing of lab and pilot production equipment• Responding of customer (hospital) complaints scientifically related with injectable products encountered during administration Show less

Subject Matter Expert (SME) at formulation development and production issues. Support of formulation development specialists by evaluating and designing of their trials. Optimization of products with various problems such as inappropriate lyophilisation cycle, stability, homogeneity, capping, sticking, disolution etc. Line extension (adding new dose or dosage form) of some commercial products. Technology transfer of first commercial products into new small scale solid production area from the… Show more Subject Matter Expert (SME) at formulation development and production issues. Support of formulation development specialists by evaluating and designing of their trials. Optimization of products with various problems such as inappropriate lyophilisation cycle, stability, homogeneity, capping, sticking, disolution etc. Line extension (adding new dose or dosage form) of some commercial products. Technology transfer of first commercial products into new small scale solid production area from the existing production area. Technology transfer support of products into our site from CMO site. Support for investigation and troubleshooting of commercial production deviations by performing lab trials, if required. Responding of authority deficiencies related with pharmaceutical development by performing lab. trials, if neccessary. Responding of customer (hospital) complaints scientifically related with injectable products encountered during administration. Technical evaluation, choosing and purchasing of lab and pilot production equipments. Show less

Galenical formulation development of sterile injectable liquid/freeze-dried and solid dosage forms. Project management, collaboration with other departments and organisation of the resources. Evaluation and selection of API sources for the projects. Preparation of pharmaceutical development reports, supporting the preparation of dossiers (CTD Module 3) according to the requirements of relevant authority. Experience for EU regulatory application requirements and knowledge for US (ANDA). Using… Show more Galenical formulation development of sterile injectable liquid/freeze-dried and solid dosage forms. Project management, collaboration with other departments and organisation of the resources. Evaluation and selection of API sources for the projects. Preparation of pharmaceutical development reports, supporting the preparation of dossiers (CTD Module 3) according to the requirements of relevant authority. Experience for EU regulatory application requirements and knowledge for US (ANDA). Using design of experiments (DoE) and Quality by Design approach. Production and FDA audit experience. Documentation and implementation of pilot production and process validations. Operating of various equipments including lab/pilot scale freeze dryer, Lyostat4 freeze-drying microscopy, high shear and fluidbed granulator, tablet pressing, film coating, bin blender, tablet hardness, friability, disintegrator etc. Show less

Optimization of newly developed and/or commercial products with various problems such as stability, homogeneity, capping, sticking, disolution etc. Formulation development of a freeze-dried product. Formulation development of a film coated tablet by using QbD approach and modeling softwares (Minitab 17 and InForm). Support for investigation and troubleshooting of commercial production deviations by performing lab trials, if required. Literature/patent research and preparation of feasibility… Show more Optimization of newly developed and/or commercial products with various problems such as stability, homogeneity, capping, sticking, disolution etc. Formulation development of a freeze-dried product. Formulation development of a film coated tablet by using QbD approach and modeling softwares (Minitab 17 and InForm). Support for investigation and troubleshooting of commercial production deviations by performing lab trials, if required. Literature/patent research and preparation of feasibility reports for possible pipeline projects in terms of formulation, production and analytical methods and equipment requirements. Regulatory variation applications: Type IA, IB and Type II variation applications were carried out to the local regulatory authority. Show less

Sterile liquid and freeze-dried vials/ampoules production responsibility. Monitoring and approving the processes such as solution preparation, filtration, filling, loading to freeze dryer, capping and visual inspection. Ensuring the production to be in compliance with GMP rules. Documentation such as logbooks, master batch records, SOPs, CAPAs and change control. Using SAP system for process flow.

Ensuring of production to be performed in accordance with the GMP rules. Responsibility of sterile injectable liquid and freeze-dryed ampoule/vial production lines in daytime shifts. In addition to this, responsibility of solid production and packaging department in night shifts. Using SAP for process flow, FDA audit experience etc.

Before I was responsible for the solid production department, I had worked as a solid production operator at tablet pressing, film coating and granulation in the beginning of my work. It lasted about 2,5 months and then continued my work as a "Assistant Production Specialist". Following routine production, process validations and new product trials. Management and organization of blue collar workers, assisting to revision of Master Batch Records and SOPs. Using SAP for process flow etc.

Sales and marketing industrial detergent, disinfectant (CIP and COP systems) and cleaning machines. Management of franchisers.

Observation of solid dosage pharmaceutical production steps and flow in such a manner that begins from warehouse.

Assisting of implementing analysis of semi/finished solid dosage pharmaceuticals.