Kalite Sistemleri Uzmanı

Founded in 1983, Sanovel is one of the leading companies within the Turkish pharmaceutical industry. Boasting an annual production capacity of 227 million units and EU GMP (Good Manufacturing Practices) certification, the company aspires to be a global pharmaceutical player. This vision is driven by robust R&D, an extensive product portfolio featuring over 60 brands and 180 products , and a dedicated team of over 1,600 individuals committed to fostering long and healthy lives. Sanovel is distinguished as the first and only Turkish pharmaceutical company to have obtained approval upon inspection by the American Food and Drug Administration (FDA), acknowledged as the world's foremost health authority, without encountering any major or critical observations. With exceptional capabilities in terms of R&D, patents and intellectual property rights, Sanovel is the pioneering company to offer equivalent products to the market in a wide range of treatment areas. Enjoying a leadership position in intellectual property competence within the industry, Sanovel has consistently maintained its status as the patent champion of the Turkish pharmaceutical industry, a title attributable to the company's exceptional work in the realm of intellectual property.

Guided by a strong vision, Sanovel centers its entire operation around sustainability, aiming for a balanced and valuable life for its hundreds of highly competent and passionate employees. The company is dedicated to contributing to the Turkish pharmaceutical industry andthe national economy, a commitment it has upheld for four decades, with the overarching goal of promoting lifelong health worldwide.

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.