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Quality Specialist

Çankaya, Turkey


Title	: Quality Specialist
Department	: Quality Department
Reporting Position	: Quality Manager

Are you passionate about driving quality processes, playing an active role in audits, and fostering a culture of continuous improvement? In this role, you will support the company’s Quality Management System and take on responsibilities ranging from internal audits to documentation control.

Key Responsibilities

Assist the Quality Manager in monitoring and maintaining the Quality Management System (QMS).

Support compliance of all activities with applicable laws, TITCK guidelines, and internal SOPs.

Contribute to tracking quality objectives and KPIs.

Participate in continuous improvement initiatives and support the application of the PDCA cycle.

Support preparation and implementation of internal audit plans.

Participate in conducting audits, identifying nonconformities, and root cause analysis.

Monitor corrective and preventive actions (CAPA) and ensure their timely implementation.

Support the preparation, revision, and archiving of controlled documents such as SOPs, forms, and policies.

Ensure completeness, accuracy, and secure storage of quality-related records.

Maintain records related to training, audits, nonconformities, and CAPA activities.

Coordinate with departments such as HR, Operations, IT, Finance, and Training to ensure alignment on quality goals.

Promote a quality-driven culture and provide guidance on quality-related topics across the organization.

Assist in identifying training needs related to GCP, regulations, and SOP compliance.

Support the organization and delivery of internal quality training.

The Quality Specialist works under the supervision of the Quality Manager and supports the effective implementation of the company’s Quality Management System (QMS). This role ensures compliance with national regulations, GCP, and internal SOPs, contributes to maintaining quality standards, and fosters a culture of continuous improvement.

Quality Specialist

Nice to Have

- Familiarity with Quality Management Systems (QMS).
- Experience in internal audits and CAPA follow-up.
- Analytical thinking and problem-solving abilities.
- Good organizational and time management skills.
- Proactive attitude with a focus on continuous improvement.

Must Have

- Bachelor’s degree in health sciences or related fields.
- 1–3 years of experience in quality management, preferably in clinical research.
- Practical knowledge of audits, SOP management, training, and regulatory compliance.
- Basic understanding of GCP, ICH guidelines, and national regulations (e.g., TITCK).
- Proficient in MS Office applications.
- Intermediate or higher English proficiency (written and spoken).
- Attention to detail and commitment to accuracy.
- Strong teamwork and effective communication skills across departments.