Serkan Şener

Leading and executing TT activities in line with created detailed project plans and Gantt charts Creating relations with each parties involved in TT projects (licencer, corporate and TPMs) Coordinating and participating in process validation (PV) studies Reviewing of the licence, manufacturing, quality and distribution agreements Responsible person against the related authorities such as MoH and MoA Responsible from the release of finished products to market Improving the QMS in the company

Responsible for quality release of pharmaceutical products in LIMS and SAP QM Quality complaints, change controls, deviation, GAP analysis, CAPAs and risk managements in Trackwise Documentation and keeping SOPs updated via eDMS Keeping in touch with contractors regarding the customer feedback on product quality Preparation of annual product quality review (PQR) reports Supplier evaluation for raw and packaging materials.

Storage of the imported and domestically produced products in accordance with J&J quality requirements, “GMP” and “GDP”. To keep the products in the warehouse under appropriate conditions and the products are shipped to the market in accordance with the SOPs. Packaging the products with the correct materials (leaflets, over print label) Improving the QMS including quality complaint handling, CAPA management and documentation management. Following up the inventory level and the stock transfer by SAP WM.

Energy and Environment