Teva Manager R&D Quality Professional 

Croatia, Zagreb 

867309428

• Supporting activities within the R&D, Zagreb and external Teva partners, 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 all documentation generated in support of new products and processes to ensure compliance with regulatory requirements
• Ensuring all OOS results and unplanned deviations with respect to R&D are fully investigated and documented and any corrective and preventative actions identified are implemented
• Evaluating changes related to development processes
• Providing Quality review of CMC regulatory submissions when required
• Reviewing R&D QA systems and processes to ensure best practice, using continuous improvement to suggest system improvements
• Assessing current and developing regulations and regulatory position in order to develop and implement changes within the business to ensure continued compliance
• Participating in inspections for new product approvals (i.e. Pre-Approval Inspections, Bioequivalence inspections)

Qualifications:

• Minimum degree in Pharmacy, Science, Engineering or similar
• Minimum of 3 years in a Quality Assurance/ Analytical control/ other related experience in manufacturing or R&D environment within the pharmaceutical industry
• Experienced in sterile operations to EU and FDA standards is desirable
• Experienced with Regulatory inspections (either hosting or being a key presenter) is desirable

Knowledge:

• Understanding of quality procedures related to Pharmaceutical Development
• Significant knowledge of ICH, ISO, US, and EU guidelines and their implementation for CMC product development
• Understanding of GMP requirements in relation to product manufacture and packaging
• Knowledge of the drug manufacturing process and analytical methods and knowledge of product development is a plus
• Knowledge of root cause analysis and Risk management
• Deep understanding of Quality Management Systems
• Experience auditing development CMC activities is a plus
• Trained in cGMP requirements
• Experience with combination products is desirable

Skills:

• Well-developed communication skills with the ability to persuade and influence all levels of colleagues, regulators and industry specialists
• Hold the highest standards of integrity, especially in decision making and the application of standards
• Ability to objectively review a wide range of technical data and feedback problems and concerns in a constructive manner
• Ability to present information to and influence
• Proven ability to manage priorities to consistently deliver on time against tight timelines
• High level of problem-solving skills, able to use a range of structured tools to complement background knowledge
• Proficiency in MS Office, SAP and Track Wise®, EDMS
• Excellent in written and spoken English

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