GMP-Driven Quality Systems Specialist

PeopleBox; Fatih; Presencial; TRY 400.000 - 620.000; Jornada completa

Descripción de la vacante

Sanovel seeks a Quality Systems Specialist to join its Quality Assurance team in Turkey. The role involves managing deviations and customer complaints, performing CAPA and risk assessments, and ensuring GMP/compliance across processes.

The candidate should have a minimum of 3 years in QA within pharma, strong GMP knowledge, analytical problem-solving skills, and good English communication. No military obligation for male candidates.

Formación

• Minimum 3 years of experience in a similar role in QA within pharmaceutical companies.
• Knowledge of GMP requirements and regulatory expectations.
• Ability to generate solutions with an analytical mindset and guide teams.
• Capability to manage all quality requirements in regulatory-compliant processes.
• Ability to manage timelines with urgency and adapt to changing priorities.
• Quality-oriented and proactive mindset.
• No military obligation for male candidates.

Responsabilidades

• Manage deviations, customer complaints, perform root-cause analysis, CAPA, and risk assessment.
• Facilitate closure of items with applicable departments for timely resolution.
• Perform CAPA effectiveness evaluations using quantitative and qualitative measures.
• Conduct internal audits, prepare audit reports, and monitor corrective actions.
• Ensure compliance with SOPs, GMPs, and global regulations.
• Support regulatory and quality training sessions for relevant personnel.
• Prepare Annual Product Review (APR) reports with cross-functional teams.
• Participate in regulatory inspections and customer audits, with documentation support.

Conocimientos

English (Advanced)

Analytical thinking

Problem solving

Quality assurance

GMP knowledge

Educación

Chemistry

Chemical Engineering

Pharmacy

Biology

Descripción del empleo

Sanovel seeks a Quality Systems Specialist to join its Quality Assurance team in Turkey. The role involves managing deviations and customer complaints, performing CAPA and risk assessments, and ensuring GMP/compliance across processes.

The candidate should have a minimum of 3 years in QA within pharma, strong GMP knowledge, analytical problem-solving skills, and good English communication. No military obligation for male candidates.