Kalite Sistemleri Uzmanı

Sanovel İlaç

Founded in 1983, Sanovel is one of the leading companies in the Turkish pharmaceutical industry. With itsstrong R&D capabilities, more than 60 brands, a broad product portfolio consisting of over 180 products, and dedicated human resources of approximately 1,750 people, Sanovel continues to work for the health of communities throughout their lives. One of Türkiye’s well-established pharmaceutical companies, Sanovel has an annual production capacity of200 million boxes of medicines, an EU GMP (Good Manufacturing Practices) certificate, and US FDA (U.S. Food and Drug Administration) approval.

With the vision of becoming a global pharmaceutical company, Sanovel continues to deliver its products tomore than 50 countries across 5 continents, strengthening its presence in international markets through its extensive export network. As a company thatoffers the first generic product in many therapeutic areas, Sanovel has been creating value for public health for more than 40 years through its future-oriented investments, innovative approach, and focus on quality and people. Continuing its operations in line with its strategic priorities and focusing on growth, globalization, and sustainability, Sanovel aims todouble its sphere of impact within the scope of its 2035 vision, further increasing its contribution to the pharmaceutical industry and public health.

We are looking for a Quality Systems Specialist to join our Quality Assurance team in Sanovel Silivri Factory.

Responsibilites

• Responsible of managing Deviation, Costumer complaints, performing root cause analysis/ CAPA/ Risk assessment.
• Facilitating the closure of items with the applicable departments to ensure completion and timely resolution.
• Performing CAPA effectiveness evaluation using quantitative and qualitative measurements
• Conducting internal audits, prepare audit reports, and monitor the implementation of corrective actions.
• Ensuring compliance with established SOPs, GMPs, and applicable global regulations and guidance.
• Supporting or conducting regulatory and quality training sessions for relevant personnel,
• Preparing Annual Product Review (APR) reports in coordination with cross-functional teams.
• Actively participate in regulatory inspections and customer audits, supporting documentation and responses as needed.

Qualifications

• Graduated from Chemistry, Chemical Engineering, Pharmacy, Biology, etc.,
• Minimum 3 years of experience in a similar role in quality assurance departments of pharmaceutical companies,
• Knowledge with GMP requirements,
• Able to generate solutions in the face of problems with an analytical perspective and guide teams effectively,
• Able to manage all quality requirements in the processes they conduct in compliance with regulations and health policies set by health authorities, and capable of being accountable for decisions and actions taken in this regard when necessary,
• Able to manage timelines with a sense of urgency and be flexible enough to adapt to changing priorities while maintaining a positive and collaborative attitude,
• Having a quality-oriented and proactive approach,
• Upper intermediate / Advanced English verbal and written communication skills,
• No military obligation for male candidates.

We believe that what makes each of us unique and valuable is our perspectives, lives, backgrounds and differences. We do not discriminate based on ethnicity, religion, language, race, age, gender, sexual orientation, nationality, disability or cultural difference, and we provide an equal employment opportunity in all human resources processes.