Senior Quality Officer (Local Center of Excellence - Commercial Quality Europe Region)

Senior Quality Officer (Local Center of Excellence - Commercial Quality Europe Region)

(Temporary)

Teva

Sofia, Bulgaria

The Senior Quality Officer will have direct reporting line to the Sr.Manager of the L2L CoE BG and will interact specifically with the Commercial Quality Heads, Commercial Quality Europe Regional team and management and needed other network partner. Thus, to ensure that each market within the EU region receives the right level of support to maintain and enhance GDP resp. GMP, authority compliance, to solve quality-related issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance to Teva standards. Moreover, will foster, maintain and develop further Quality compliance culture across the Commercial Quality Europe Region.

How you’ll spend your day

• The L2L CoE Senior quality officer is the Quality partner of Commercial Quality Europe Region and supports and ensures the local quality compliance of the markets in Europe; and
• Handles quality items, amongst others like processing market compliance maintenance, market compliance monitoring, handling quality process handling like change control, supplier list qualification
• Connects in deviation, CAPA, PQR processing to support the compliance of the countries
• Ensures compliance with Teva's global standards, regulatory guidelines plus expectations and cGMP/GDP requirements
• Ensures support for key performance metrics and market quality management review
• Interprets internal or external business issues and recommends solutions/best practices
• Ensures local operational implementation of Quality Management System in compliance with GMP&GDP and Teva Corporate standards
• Proposes continuous improvement of processes based the QMS of CQ Europe Region
• Ensures inspection readiness, continuously identify opportunistic areas for improvement
• Promotes a Quality Culture within Commercial Quality

Your experience and qualifications

• Bachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related science-based degree
• Experience: 3 years of experience as a Quality member with technical, team management, and operational responsibility
• Demonstrated knowledge and working experience with government regulations for the cluster
• In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
• Working knowledge of pharmaceutical operations
• In-depth understanding of GMP & GDP & new authority regulations
• Experience with development and implementation of Quality Systems and application of risk assessment tools
• Proficient computer skills in current software including MS Office
• Excellent English language skills
• Continuous professional development