Quality Assurance Supervisor / Executive (Quality Management)

Mefar İlaç Sanayii A.Ş.

At MEFAR, we are looking for a Quality Assurance Supervisor / Executive (Quality Management) to join our Quality Assurance Department and ensure the effective implementation, maintenance, and continuous improvement of our Quality Management Systems.

We welcome professionals with experience in quality systems, audit management, supplier qualification, and team leadership who are committed to quality and continuous improvement.

Key Responsibilities

• Ensure the effective implementation, maintenance, and continuous improvement of ISO 9001 and ISO 13485 Quality Management Systems.
• Lead the Quality Management team, set individual objectives, evaluate performance, and support team development.
• Ensure the preparation, maintenance, and effective implementation of Quality Management System documentation.
• To coordinate Management Review meetings; to prepare and present pre-evaluation reports, meeting presentations, reports.
• To ensure the planning and coordination of internal audit, GMP/process audit, certification, customer audits and authority inspections. To accompany site tours and documentation processes throughout the audits and inspections.
• Ensure the timely development, implementation, and completion of corrective and preventive actions (CAPA) in response to audit / inspection findings.
• Coordinate supplier qualification, supplier audits, risk assessments, and the maintenance of the Approved Supplier List.
• To ensure that the quality targets, risk analyses, deviation and change management processes related to the department are carried out effectively.
• Maintain cross-functional coordination and communication regarding Quality Management System activities and provide regular updates to the Quality Assurance Manager.

Qualifications

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, Biology, or a related field.
• Preferably in the pharmaceutical industry, to have at least 5 years of experience in the fields of Quality Assurance and Quality Management Systems.
• At least 2 years of team leadership or managerial experience.
• Knowledge of ISO 9001 and ISO 13485 standards, with completed internal auditor training and practical audit experience.
• Experience in GMP, quality systems, audit management, CAPA, and supplier qualification processes.
• Good command of English.
• Proficiency in SAP, MS Office and other relevant office applications.
• Strong analytical, organizational, planning, communication, and team leadership skills.