Senior Professional, R&D Quality Assurance

Senior Professional, R&D Quality Assurance

Teva

Zagreb, Croatia

How you’ll spend your day

• Primarily supporting R&D activities in Zagreb, with additional responsibility to support other Teva R&D units as part of Quality Shared Services
• Opportunity to learn about and be involved in other drug delivery methods through shared services, such as respiratory or implants
• Ensure that current Good Manufacturing Practices, Teva Global Policies and Standards and relevant Regulatory Authority requirements are met
• Understanding of Teva pharmaceutical development process (including the QMS), and contributing to Quality related decisions that affect product development
• Reviewing and approving documentation generated in support of new products and processes to ensure compliance with regulatory requirements
• Review of starting materials documentation as well as finished product documentation
• Providing Quality review of CMC regulatory submissions when required
• Support Vendor Approval Program (review of vendor documentation, QTAs, etc.)
• Investigating OOS results and defining corrective and preventative actions
• Evaluating changes related to development processes
• Train and maintain proficiency with computerized systems (Glorya, TrackWise, Veeva, Studium, IT system etc.).

Your experience and qualifications

Qualifications:

• Minimum degree in Pharmacy, Science, Engineering or similar
• Minimum of 2 year in a Quality Assurance/Analytical control/other related experience in manufacturing or R&D environment within the pharmaceutical industry
• Experience in sterile operations to EU and FDA standards is desirable

Knowledge:

• Knowledge of ICH, ISO, US, and EU guidelines
• Understanding of GMP requirements in relation to manufacture and packaging
• Understanding of Quality Management Systems
• Understanding of the analytical methods and knowledge of product development and manufacturing is a plus

Skills:

• Good communication skills
• Good interpersonal and communication skills as well as organizational skills
• Ability to communicate complex issues to affected departments and solve problems
• Orientation to achieving results and attention to detail
• Proficiency in MS Office; knowledge of SAP, Track Wise® and EDMS is desirable
• Very good in written and spoken English