As 9100:2016 Rev. D providing all the requirements; company internal audits, YYG meeting, process analysis and providing documents related to all units, quality targets DFI, customer satisfaction, timely delivery, calculation of monthly wastage rates, etc.Making statistical process studies Interpreting technical drawings Active use of the SAP program.ROKETSAN, TAI-TUSAŞ, EYDEP, ASELSAN, SDT Defense audits were concluded successfully and orders were increased.

Following up safety and environmental regulations and review company procedures in line with regulations. Providing specialist Security advice, guidance and support to the Quality operations team. Actively participating in Job Security meetings, audits and initiatives. Providing input into the development of the operational safety cases. Following up periodic controls of safety, health and environmental requirements. Ensuring Operational Job Support systems and processes are consistent and aligned with operational and corporate standards.

I worked as responsible for the development of business security systems, processes, plans and procedures that will support operational activities.Providing specialist security advice, guidance and support to the Quality operations team.Ensured Monthly following the safety indicators of each entities and generation of a monthly report based on these indicators in comparison with previous year and budgetTo create a common safety basis in the risk region: safety policy, procedures, risk evaluation

ISO-EN 9001:2015 Quality Management System,Establishment and development of ISO-EN 45001:2018 Occupational Safety and Environment (14001:2015) standards.ISO 22716:2007 (Cosmetic Good Manufacturing Practices Standard),GMP (Good Manufacturing Practices), Laboratory GLP (Good Laboratory Practices) and Warehouse GDP (Good Warehouse Practices), ISO 22000 HACCP Food Safety Management System, ISO IEC 17025 laboratory Accreditation, monitoring and inspection.Preparation of files related to in-house quality management systems and practices, reporting and creation of related documentation.Managing the processes related to customer demands and complaints,Organization and follow-up of internal audit activities,Preparing and presenting weekly, monthly or quarterly reports.

Daily monitoring of production activities, batch documentation review, handling deviations, conducting and following up quality audits, preparation of yearly QA reports, taking a role in Quality systems review and improvement activities,On job training for all production operators.Performance management of production operators.Following up all production activities in the processing area.To assist manufacturing plan and inventory follow-up.To prepare, keep up to date and follow-up all the documentation relating to production operations.

Following up CAPAsTo Leading Change Control SystemPreparation of yearly Product Quality reportsConducting and following up cGMP AuditsFollowing up cGMP Audits and SOPsEnsuring Quality systems review and improvement activitiesPreparation of yearly Product Package reportsEnsuring Quality systems review and improvement activitiesFollowing up Standard Operation Procedures preparation and updateEnsuring compliance with the approved SOPs.On job training for all production operators.The calibrations of the production equipments with coordination.Production weekly schedule.To assist manufacturing plan and inventory follow-up.Followed up all production activities in the processing area.Ensuring the standardization of packaging materials and processes in the department.Ensuring that the process is accurate and reliable by following all stages of production, based on the Validation Protocol.

Cephalosporins, Beta-lactam in the field of primary production, solid production (dragee and suspension) lines and secondary box in the machines; As a result of the Integrated System Installation and Process Improvement, the monthly production of 550 thousand boxes of antibiotics has been increased to 2.3 million units.By making production controls within cGMP standards, I have made a significant contribution to the production efficiency based on the SAP System.GMP compliance activities,Deviations, Change Control System, CAPA System (Following up process any relevant corrective and preventative actions), Customer Complaints, Recalls, Documentation, Annual Product Reviews. Daily monitoring of production activities, batch documentation review, handling deviations, conducting and following up cGMP audits, preparation of yearly Product Quality reports, taking role in Quality systems review and improvement activities, On job training for all production operators. Ensuring the standardization of packaging materials and processes in the department. Confirming of quantifiable specifications in the particles, temperature, humidity, pressure and documentations, Standardization of 2D applications, Following up in charge of validation and QA activities (Process&Cleaning Validation, Equipment Qualification). Performing investigations related to complaints, interpretation of complaints and determining the root cause.