Quality Systems Specialist (Fixed-Term)

About the role

Sanovel is seeking a Quality Systems Specialist to join its Quality Assurance team at the Silivri factory. The role focuses on managing deviations, customer complaints, and ensuring compliance with GMP and global regulations.

Key responsibilities

• Manage deviations, customer complaints, perform root cause analysis, CAPA, and risk assessments.
• Facilitate closure of items with relevant departments to ensure timely resolution.
• Evaluate CAPA effectiveness using quantitative and qualitative measurements.
• Conduct internal audits, prepare audit reports, and monitor corrective actions.
• Ensure compliance with SOPs, GMPs, and applicable global regulations.
• Support or conduct regulatory and quality training sessions.
• Prepare Annual Product Review (APR) reports in coordination with cross‑functional teams.
• Participate in regulatory inspections and customer audits, providing documentation and responses.

Required profile

• Graduated in Chemistry, Chemical Engineering, Pharmacy, Biology or related field.
• Minimum 3 years of experience in quality assurance within the pharmaceutical industry.
• Strong analytical mindset, able to generate solutions and guide teams.
• Proactive, quality‑oriented attitude with ability to manage timelines and adapt to changing priorities.
• Upper‑intermediate to advanced English communication skills.
• No military obligation for male candidates.

Required skills

• Good Manufacturing Practices (GMP) knowledge.
• CAPA management.
• Root cause analysis.
• Risk assessment.
• Internal audit execution.