Meltem Arıtürk Email & Phone Number

Istanbul, Turkey

•Responsible for the execution of more than 30 R&D projects•Project coordination with BD for in-licensing and technology transfer projects•Tracking the compliance of the projects to time plan and removing the barriers that effect the project plan negatively• Partnered with cross-functional teams to ensure the development of the product that is suitable for all possible markets’ regulations •Taking an active role in the selection of projects and making project prioritization

İstanbul/Türkiye

•Auditing the contract manufacturers and the suppliers of raw materials and packaging materials.•Preparing and distributing the SOPs and giving the training when necessary, assuring that the procedures are effectively used.• Evaluating the deviation forms. •Evaluating the complaints and giving the feedbacks to production sites.•Answering the questions of Health of Ministry about the quality and providing technical documentation to support Regulatory Affairs Dept.• Controlling the analytical method validations, process validations and evaluating datas.• Tracking the GMP contracts.• Following the current versions of USP, EP, BP and publishments. Revising the specifications and methods according to the changes.• Preparing the master batch dossiers (praparing raw material, packaging material, finished product spesifications/preparing the production methods, the recipies and packaging designs.) • The member of SAP validation team in order to create a quality system documentation and following up the validity of the system based on documentation.• Cooperating with quality control, quality assurance, R&D department of production sites and supporting the planning, import & export, foreign trade departments about quality requirements.

Tekirdağ, Türkiye

•Executing R&D activities and carrying out the in-process controls that related these operations.•Carrying out the requirements of GMP and ISO 9001.•The inventor team member of below patents:WO 2007/062675: Method for producing metal salts of losartan. Ulkar Kimya Sanayii Ve Ticaret June 2007EP1963309: Method for producing metal salts of losartan. Ulkar Kimya Sanayii Ve Ticaret September 2008

Lisans Derecesi, Chemical Engineering

Lisans Derecesi, İşletme

Sertifika Programı, Organizational Leadership