Selen Aykaç Karakaş Email & Phone Number

Ankara, Türkiye

-To prepare process validation studies protocol-Informing the production team and coordinating with the team for the validation production for which the protocol is prepared-Participate in validation productions,-To evaluate and report the results of the validation studies completed-Participate in and report on the qualification of equipments,-Writing and performing PQ tests-To follow the production process and documantation system, to create Deviation, DK (Change Control) or CAPA (Regulatory and Preventive Action) via Qmex if necessary in an unusual situation,-To follow the opened deviation, DC and CAPA transactions and to take the necessary actions to close them,-Assist with commissioning and IQ-OQ testing and contol the documantation-Participating in internal audits, reporting and ensuring closure of audit findings

Ankara, Turkey

-Being responsible for production processe-To follow the production process and documantation system, to create Deviation, DK (Change Control) or CAPA (Regulatory and Preventive Action) via Qmex if necessary in an unusual situation,-To follow the opened deviation, DC and CAPA transactions and to take the necessary actions to close them,-Writing the SOP (Standard Operation Procedure) and usage instructions of the areas andequipment and training the relevant personnel,-Assist with commissioning and IQ-OQ testing and contol the documantation-Writing and performing PQ tests-Responsible for production personnel and their work.-Creating and archiving annual, monthly and weekly production plans.

Ankara, Türkiye

-Being responsible for all processes from raw material to finished product (raw materialcontrol,granulation processes,tablet printing processes,capsule filling processes,coatingprocesses,blistering and boxing processes) in the non-sterile production unit where solidproduction is made and checking MBR (production files).-Carrying out packaging line controls and periodically checking their suitability andchecking PBR ( packaging files).-To follow the production lines, to create Deviation, DK (Change Control) or CAPA (Regulatory and Preventive Action) via Qmex if necessary in an unusual situation,-To follow the opened deviation, DC and CAPA transactions and to take the necessary actions to close them,-After each production and packaging process, confirming via SAP and using SAP to trackstock, open and follow up a fault record.-Writing the SOP (Standard Operation Procedure) and usage instructions of the areas andequipment and training the relevant personnel,-Assist with commissioning and OQ testing of new equipment,-Using 5S, GMP, HSE problem solving methods and lean manufacturing techniques in studies.-Responsible for production personnel and their work.

-Performing physical and chemical analyzes of the finished product-Usinig laboratory devices (HPLC, GC, ICPMS, UV etc.)-Checking and interpreting the results of the analysis and filling out the product file-Performing qualification and validation analyzes-Assisting with personnel training

-Business Internship,-5S Implementation,-Creation of MSDS,-Checking the proper separation and collection of waste-Making area observations and identifying deficiencies

-Powder Production,-5S, Kaizen, 6 sigma, problem solving methods research and review,-Preform tracking

-Performing the analysis of materials such as food, clothing, toys, parking materials andchecking their compliance with standards,-Usinig laboratory devices (HPLC, GC, ICPMS, UV etc.),-Examining the standards.

Bachelor'S Degree, Chemical Engineering, 3.3/4

Master Of Science - Ms, Chemical Engineering