Fatih DÖNMEZ

At ophthalmic and parenteral drug manufacturer;

Lead and manage Validation and Qualification activities and Team. (PV, CV, HVAC, CA, CSV, Water and equipment qualifications etc)

To establish and maintain Contamination Control Strategy

Ensure consistency of quality related processes and procedures within the Departments such as QC,Production and Technical at site

To lead quality systems and GxP related activities such as technical and medical complaints, deviation, incident, CAPA management, change control, internal audits, reprocess, recall and returned products,data integrity, trainings are in place

Ensure the preparation of product quality reviews annually

Prepare company for GMP audits performed by local and abroad authorities

Ensure the preparation of annual plans such as validation master plan, trainings, internal audits etc. Establish and follow up KPI system (using Quality metrics and EFQM Model) Perform audits for Suppliers at High Risk level Prepare Quality Management Reviews and take corrective actions as per output of QMR

Prepare Quality Assurance Annual Budget (Capex, Opex)

At non-sterile Solid, Semi-solid, Liquid manufacturer plant

To lead Quality activities and product releases as per regulations

• To lead Qualification Plan of All GMP critical equipments, utilities and computerized system.

• To monitor and assessment of product quality life cycle.

• To establish Quality by Design concept at company

• Establishment KPIs system and monitoring

• To activate and qualification of main systems and utilities

• To perform supplier audits

• To establish new plant including 2 building for parenteral hormone and solid dosage form finished products according to design and concepts of cGMP Requirements.
• To perform and qualification of main systems and utilities
• To establish Pharmaceutical Quality Management System

• At parenteral LVP, Ampoule, Vial and Lyophilized drug product Manufacturer
• Lead and manage Validation and Qualification activities and Team.
• (PV, CV, HVAC, CA, CSV, Water and equipment qualifications etc)
• Ensure consistency of quality related processes and procedures within Departments such as QC,Production and Technical at site
• To lead quality systems and GxP related activities such as technical and medical complaints, deviation, incident, CAPA management, change control, internal audits, reprocess, recall and returned products,data integrity, trainings are in place
• Ensure preparation of product quality reviews annually
• Prepare company for GMP audits performed by local and abroad authorities
• Ensure preparation of annual plans such as validation master plan, trainings, internal audits etc.
• Establish and follow up KPI system (using Quality metrics and EFQM Model) Perform audits for Suppliers at High Risk level
• Prepare Qulity Manangement Reviews and take corrective actions as per output of QMR
• • Prepare Quality Assurance annual Budget (Capex,Opex)
• In addition to Quality Assurance manager position
• i was working as Technology Transfer Manager as second title between Jan 2017 to Feb 2018
• Responsibilities was as Technology Transfer Manager following
• Transfer enjectable products which are currently manufactured in Jordan Enjectable Site such as LVP, ampoule, vial and Lyophilized powders to Turkey site.
• Ensure coordination between Jordan R&D/Strategic planing and Turkey.
• Asses risk management, phisibility and producibility,
• Plan and follow up method verifications and stability studies
• Lead and ensure coordination between departments such as Supply chain, production, Quality Control and Technical Department during pilot batch production
• Lead and take part in pilot batch production and process validations
• Ensure and follow up preparation of CTD Modules

• Quality Assurance Activities at Beta-lactam solid and injectable plant

• Quality Assurance Activities at API manufacturer plant