Quality Assurance Manager

Quality Assurance Manager

Teva

Sofia, Bulgaria

How you’ll spend your day

• Register in Teva approved electronic deviations management system all major and critical deviations occurred during manufacturing, packaging, testing, etc. of medicinal products, medical devices, food supplements and cosmetics supplied by Teva 3rd Party European Suppliers
• Assess the criticality of notified deviations and expedite in case of critical deviations or issues that potentially could lead to Regulatory Body notification or recall
• Evaluate the investigation reports received from Teva 3rd Party European Suppliers and ensure that the investigations are performed to meet the Teva requirements and according to quality agreements in place. Ensure that the quality and patient safety impact is properly assessed, the root cause is identified and relevant CAPAs are defined
• Initiate Notification to Management of Serious Incidents when needed according to Teva internal procedures. Support QRMs and coordinate the preparation for reporting the case to Quality Alignment Meeting. Collect and summarize all applicable data and documents, e.g. complete investigation report, Health Hazard assessment, toxicological assessment, etc
• In case of decision for market action, support QRMs in terms of preparation for the internal Market Action Committee meeting
• Handling of requests from other Teva sites regarding quality deviations observed on received deliveries
• Handling of requests to assess the impact of temperature deviations on deliveries. Request of a statement from the BRS or coordinate the internal preparation of the assessment if Teva is acting as BRS
• Perform deviations trending according to internal procedures in place. Initiate trend investigation records if needed
• Perform Impact and Risk assessment related to Global Notifications to Management (GNTM). Participate in Critical Vendor Issues meetings
• Monthly KPI reporting to EMSO EMEA Quality Management
• Work in accordance to all applicable corporate and regional standards and procedures
• Lead or participate in self-inspections within EMSO Quality EMEA
• Maintain the Regional Quality SOPs for Deviations, Investigations, CAPAs and Notifications to Management in accordance with Teva Corporate Policies and GMP requirements
• Lead or support of projects within the department EMSO Quality EMEA to ensure compliance with internal standards
• Initiation and execution of continuous improvement projects
• Host Quality Control Center.
• Represent EMSO Quality EMEA in Supply Chain – Quality operational meetings to prevent write offs and out of stock situations

Your experience and qualifications

• Master Degree in Pharmacy, Chemistry, similar Natural Sciences, Engineering or other relevant education.
• 5+ years of experience in the pharmaceutical industry in the field of manufacturing, quality control, validation, quality assurance, regulatory affairs, etc.
• Preferable experience in manufacturing and/or quality control of sterile products
• Good command of written and spoken English language
• Good interpersonal, communication and organizational skills
• Ability to solve problems
• Good understanding of analytical methods, manufacturing processes and quality systems in pharmaceutical industry
• Good knowledge on pharmaceutical regulations and guidelines, understanding of cGMP
• Proficiency in MS Office

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