Kerem Dogan
About
Kerem Dogan is from 土耳其 伊斯坦布尔 伊斯坦布尔. Kerem works in the following industries: "生物技术", "医疗设备", and "制药". Kerem is currently Mesul Müdür at Avis İlaç A.Ş.. In Kerem's previous role as a Arge yoneticisi at TOBIO NOVELFARMA , Kerem worked in until Nov 2021. Prior to joining TOBIO NOVELFARMA , Kerem was a Kalite kontrol müdürü at ONKO KOÇSEL İLAÇLARI and held the position of Kalite kontrol müdürü. Prior to that, Kerem was a Eğitim ve uygulama uzmanı at Likrom Analytical Solutions Marketing Corp.. from Nov 2017 to Feb 2018. Kerem started working as Kalite kontrol Şefi at The BirgiMefar Group in pendik istanbul in May 2016. From Jan 2014 to May 2016, Kerem was Ar-ge Sorumlusu at Pharmet Sağlık Gıda Ürünleri, based in İstanbul, Türkiye. Prior to that, Kerem was a R&D Technology Transfer Analytical Specialist at Abdiibrahim Pharmaceuticals from Aug 2010 to Dec 2013. Kerem started working as R&D Analytical Specialist at Bilim Pharmaceuticals in Nov 2004.
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Kerem Dogan's current jobs
Kerem Dogan's past jobs
- Coordinate the analyse programs for team members, - Following up analitical analysts and their weekly programme, - On-the-job training of new analysts and implementation of standard operation procedures after training, - Developing methods for generic products and validation of the methods, - Preparing, controlling and auditing of technical documents of analysed final and stability products, - Preparing and editing Stability Protocols, Method Validation Protocols, API Protocols and reports, - Co-working with business partner companies and preparing several kinds of documents for contracted products, - Analyzing stability samples and final products periodically by using wet chemical methods and chromatographic instruments such as HPLC, UPLC, GC, UV, - Processing, calculating and reporting analysed samples.
As a team member of project group in R&D Technology Transfer Department; - Coordinate the analyse programs for team members, - Following up analitical analysts and their weekly programme, - On-the-job training of new analysts and implementation of standard operation procedures after training, - Developing methods for generic products and validation of the methods, - Preparing, controlling and auditing of technical documents of analysed final and stability products, - Preparing and editing Stability Protocols, Method Validation Protocols, API Protocols and reports, - Co-working with business partner companies and preparing several kinds of documents for contracted products, - Analyzing stability samples and final products periodically by using wet chemical methods and chromatographic instruments such as HPLC, UPLC, GC, UV, - Processing, calculating and reporting analysed samples.
Core Role; As a team member of project group in R&D Department; - Implementation and reporting to stability, final product, raw material analyses, analytical method validation and analytical method development studies with using HPLC, UPLC and dissolution equipment according to GLP and cGMP, - Documentation of regulation studies and CTD format documentation , - Revising to department standard operation procedures, preparation of raw material, final product and test methods of products, - On-the-job training of new analyst and implementation of standard operation procedures after training, - As R&D Laboratory references and standards purchasing responsibility; responsible to purchasing and following stocks of references and standards with using SAP / MM modules
Management of Quality Control (Finish Product); - Have a professional understanding of GMP, GLP and their aspects in pharmaceutical industry. - QC and QA system in pharmaceutical ındustry. - Process validation - Cleaning validation - Equipment qualification (validation and verification) - Change control - Customer complaint - Finish Product analysis approval - To prepare QC laboratory for the internal & external audit - Manage the laboratory equipment qualification. - Change the all SOP and analysis method