The opportunity
The main purpose of this role is to contribute to the operational maintenance of Quality Management System in compliance with GxP/ISO 9001 Standards in Bulgaria. Also, the Senior Specialist Commercial Quality acts as a Responsible Pharmacist and provide GxP guidance and quality oversight to Teva warehouse ensuring local GxP deliverables of.
How you’ll spend your day
• Support and maintain Quality Management System setting out responsibilities, processes and risk management principles in relation to the scope of WDA activities (with a focus on narcotic products management), ensuring GDP/ISO 9001 compliance and public service obligations
• Support the maintenance of Standard Operating Procedures and Working Instructions as per Teva standard and in compliance with the national regulations
• Define and systematically review the distribution activities. Identify critical steps and significant changes, justify, and validate, where relevant
• Monitor effectiveness of Quality Management System, based on established KPIs and periodic review of processes
• Manage the quality complaints
• Manage the deviations from established procedures and documented and investigated
• Manage destruction activities
• Ensure that appropriate corrective and preventive actions (CAPA) are taken to correct deviations and prevent them in line with the principles of quality risk management
• Ensure that customers are approved
• Support the prompt local coordination and execution of recall activities
• Support the self-inspection activities based on prearranged program and necessary corrective measures
• Ensure the final disposition of pharmaceutical products
