Greater Tekirdag
Ensuring the continuity of management systems ISO 9001: 2008 ISO 9001: 2015 Suppliers; • Making evaluations • Making inspections • Following improvements ISG • Risk assessment • Measurements of Goals • Training Performance management • Determination of KPIs • Performance measurements QDMS Analysis of customer complaints Business processes • Tracking • Ensuring continuity • Revision • Creating SAP QM Module
- Lead root cause investigations and corrective action and preventive action activities to address customer complaint, internal non-conformance and audit observations. - Prepared 5Why's Rootcause Analysis, Fishbone Diagram, Control Plans and other quality tools - Conducted in research projects related to new products, sustainable quality improvements and cost reductions - Standardization of the new product, making necessary documentations ( process flow chart, RM Specification, Bill of Material etc.) - Collaborated selection suppliers to improving their Quality Management system, service and quality levels. - Managed inline process control, incoming inspection, finished good release process. - Ensure full compliance for ISO 9001 and EOC Global QMS and coordinating certification activities as Quality Management Representative.
I am a part of organization as a process quality engineer -Production controls have been made in a shift system. The conformity of the products been controlled and monitored to the customer specifications in the production processes within the framework of the defined quality control plan. -Process studies have been carried out in compliance with the ISO9001:2008 standards and the production management systems. -Necessary flowcharts, procedures and instructions have been prepared within the scope quality management Bu belge adayin kendisi tarafindan 29.02.2020 04:26’te olusturulmustur. - This document was created by the candidate herself/himself in 29.02.2020 04:26 2 / 6 systems. -Periodic validation / qualification studies of new personnel, new machines and existing have been carry out. -Relevant internal audits have been made within the framework of the annual audit plan. -Periodic calibrations and performance analyzes of quality, R&D and production test equipment have been made. -Control activities have been inspected and improved within the production areas. -Incoming controls have been made in critical situations.
Product and Process validation and qualification studies Process and analytical test method verifications. -Planing and performing analytical method suitability studies and technoogy transfer studies form R&D to QC Develop solid and liquid products projects for EU and TR market. HPLC, UPLC, UFLC, UV, AAS, GC method development, technology transfer and verification studies. -Viscosimeter, pH meter, Density, Particle size determination analysis and usage specific equipments for these analysis. -Validation protocol preparation. - Perfoming validation analysis according to validation protocol -Validating method according to protocol and prepare method validaition report. -Prepare analysis certificate for raw materials, APIs, bulk and final products. -Method revision studies and according to major variaitons revalidate method validation.