Quality Systems Specialist
Çerkezköy, TR
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 %