Quality Assurance Specialist

SANOFİ İLAÇ SAN. VE TİC. A.Ş.

Key Responsibilities

• Management of Proactive risk studies (FMEA) in the site,
• Preparation of Site risk master plan,
• Management of Site Quality Risk Profile,
• Management of Transport validation studies,
• Management of unannounced inspections that are performed by Quality systems team to all GxP related areas related with improving the quality systems and controlling the implementation of GMP rules in the site,
• Performing on-site supplier audits located at local and foreign countries as a Sanofi Global auditor. Preparing the audit report and follow-up the CAPAs on global system,
• Performing  annual suppler assessments for all materials received from suppliers,
• Manage the alternative supplier projects,
• Attending GMP/ISO9001 Quality Management System self-inspections, reporting and following the CAPA reports,
• Preparation before the customer and authority inspections to be performed at facility, attending these audits and preparing the corrective and preventive action report related to own department after the audit and performing the actions on due time,
• Contributing the risk analysis studies during production, analysis and other process,
• Contributing the routine and new employee GMP trainnings,
• Preparing the standard operation procedures related with the works in the department,
• Contributing the studies in order to comply with the department budget and targets,
• Providing technical support to company personnel for the studies he/she perform,
• Supporting the preparation and development of ISO9001, ISO27001, ISO14001 and OHSAS 18001 quality, environment, occupational health and safety management systems and performing the applications.

Requirements & Qualifications

• Bachelor’s degree in chemical engineering, chemistry, Pharmacy departments,
• Minimum 3 years of experience in Quality Assurance activities,
• Knowledge with GMP and GLP requirements,      
• Able to use MS Office, and global systems LIMS, SAP effectively,
• Upper-Intermediate level in English,
• Commit to customers, team oriented,result-focused,good communication skills.