Teva Senior Professional R&D Quality Assurance 

Croatia, Zagreb 

968233435

• Supporting activities within the R&D Zagreb to 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
• Investigating OOS results and defining corrective and preventative actions
• Evaluating changes related to development processes
• Review of starting materials documentation
• Providing Quality review of CMC regulatory submissions when required

Qualifications:

• Minimum degree in Pharmacy, Science, Engineering or similar
• Minimum of 1 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

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