Emre Şen Email & Phone Number

*****Highlights of Qualification Professional experience in Production, Quality Assurance, Quality Control in Pharmaceutical - Health Industry with highly developed technical and management skills Analytical thinking, foresight, good communicator, energetic, open-minded, solution oriented Strong knowledge of cGMP’s Very good computer skills. Excel, Word, PowerPoint, SAP, Outlook, TrackWise (AQWA)*****Key Areas of Expertise Project management Pharmaceutical manufacturing Perform the duties of the QP (Qualified Person) in accordance with EU directives, Turkish Health Ministry directives and company policies Implementation of both local and international regulations in pharmaceuticals industry Management of daily QA activities Quality documentations accordance with cGMP Batch release CAPA management Recall management Supplier management Audit management Validation, Qualification and Temperature Mapping Studies Reviewing – Preparing reports and procedures cGMP, GDP and GSP (GWP) training for staff Quality control Supporting to MS&T department for the product transfer processes with the quality assurance perspective and the requirements. (Experiences for the 5 product transfer process to the contract manufacturer and the process validation reports, stability studies review – approval processes.)*****Skills Keywords Production, Quality Assurance, Quality Control, CAPA Management, MAH Auditing, Validation, Qualification, HSE, International Communication, Batch Release, Documentation, Contract Manufacturing, Project Management, People Management, Temperature Mapping

Listed skills include Gmp, Change Management, Quality Management, Warehouse Management, and 21 others.

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  Cumhuriyet University / Turkey

  Chemical Engineer