Quality Systems Specialist - GMP, CAPA & Compliance

Sanovel İlaç; Silivri; On-site; TRY 300,000 - 420,000; Full time

Job summary

Sanovel İlaç seeks a Quality Systems Specialist to join the Quality Assurance team in Turkey. The role focuses on deviation management, customer complaints, CAPA, risk assessment, and audits to ensure GMP and regulatory compliance.

The candidate should have a degree in Chemistry, Chemical Engineering, Pharmacy, or Biology and at least 3 years in a pharmaceutical QA role, with strong English and regulatory awareness.

Qualifications

• Graduated from Chemistry, Chemical Engineering, Pharmacy, Biology, or related fields.
• Minimum 3 years of quality assurance experience in pharmaceutical QA.
• Knowledge of GMP requirements.
• Analytical problem-solving with ability to guide teams.
• Ability to manage timelines and adapt to changing priorities.

Responsibilities

• Managing Deviation, Customer complaints, root cause analysis, CAPA, risk assessment.
• Facilitating closure of items with departments to ensure timely resolution.
• Performing CAPA effectiveness evaluation with quantitative and qualitative measures.
• Conducting internal audits and monitoring corrective actions.
• Ensuring compliance with SOPs, GMPs, and global regulations.
• Supporting regulatory and quality training for relevant personnel.
• Preparing APR reports with cross-functional teams.
• Participating in regulatory inspections and customer audits with supporting documentation.

Skills

GMP knowledge

Deviations handling

CAPA implementation

Audits & inspection

Regulatory compliance

Education

Bachelor's degree in Chemistry / Chemical Engineering / Pharmacy / Biology

Job description

Sanovel İlaç seeks a Quality Systems Specialist to join the Quality Assurance team in Turkey. The role focuses on deviation management, customer complaints, CAPA, risk assessment, and audits to ensure GMP and regulatory compliance.

The candidate should have a degree in Chemistry, Chemical Engineering, Pharmacy, or Biology and at least 3 years in a pharmaceutical QA role, with strong English and regulatory awareness.