Quality Systems Specialist

Job Purpose

Key Responsibilities

• Execute Quality Assurance activities in compliance with GMP, Ministry of Health regulations, and company Quality Management System requirements,
• Plan, coordinate, execute, and document validation and qualification activities, including process, cleaning, and transportation validation,
• Prepare, review, maintain, and control quality documentation, including SOPs, protocols, reports, and related QA documents,
• Manage Change Control, Deviations, CAPA, Risk Assessment, and Quality Agreement processes, ensuring timely implementation and follow-up of required actions,
• Participate in internal, external, regulatory, and supplier audits, and support the implementation and monitoring of corrective and preventive actions,
• Coordinate supplier qualification activities and collaborate with cross-functional teams to ensure supplier compliance,
• Work closely with Manufacturing, Quality Control, Regulatory Affairs, and Procurement to ensure timely execution of Quality Assurance activities,
• Develop and monitor Validation Master Plans, oversee validation studies, and identify revalidation requirements,
• Deliver GMP and Quality Assurance training and support the development of a strong quality culture across the organization,
• Contribute to continuous improvement initiatives and support the achievement of quality and operational excellence objectives.

Required Education

Required Skills and Experience

• Bachelor’s degree in Chemistry, Chemical Engineering, or a related scientific discipline,
• 3-4+ years of Quality Assurance experience in the pharmaceutical industry,
• Strong knowledge of GMP regulations and quality documentation systems,
• Proficient in Microsoft Office applications,
• Analytical, systematic, and results-oriented mindset with strong teamwork and communication skills,
• Professionally proficient English is preferred,
• Completion of military service required for male candidates,
• Residing in or willing to relocate to Çerkezköy, Kapaklı, Çorlu or Ergene within a short time.

Technical Competencies

Required Behaviours and Competencies

Required Languages

Travel required in %