Teva Global Quality Auditor 

Croatia, Zagreb 

986008119

• Scheduling, preparation, conduct, documentation and follow-up of assigned GxP audits in accordance with Teva corporate standards
• Initial assessment of audit deficiencies, corrective and preventive actions, and overall vendor/site compliance status based on regulatory GMP requirements and specific Teva requirements
• Communication to stakeholders on potential risk and product impact from observations and GMP deficiencies found during your audits
• Provide support to Teva site with supplier qualification issues and supplier risk assessment based on audit result when required/requested
• Support notification to management process in case of critical audit findings in collaboration with audit regional lead and audit plan owner
• Regular participation in GMP trainings (internal/external)
• Must be able to travel approximately 50% --both domestic and international

• Undergraduate/BSc degree in applicable discipline required
• Minimum 7 years of experience required as a Quality Auditor in a regulated pharmaceutical environment with a minimum of 50 audits performed in a Lead Auditor role
• Uses best practices and knowledge of internal or external business issues to improve products/services or processes
• Typically resolves complex problems or problems where precedent may not exist, takes a new perspective using existing solutions
• Participates in project teams
• Acts as a resource for colleagues with less experience
• Requires in-depth knowledge and experience of audit management and execution
• Works independently; receives minimal guidance
• Strong working knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), the rules governing medicinal products in the European Union, WHO and other regulatory requirements
• Fluency in written and spoken English
• Experience preparing technical/complex written materials that are accurate, clear, logical, well organized and grammatically sound
• Contact with Regional leaders, Global Audit Group team members, and External Vendors
• Excellent written and verbal communications and interpersonal skills
• Strong presentation skills
• Ability to work in cross functional teams, prioritize workloads, and be responsible for the expected deliverables
• Manage problem solving and conflicts effectively within the team
• Innovative/creative in the areas of his/her work
• Willingness to challenge boundaries
• Organization and attention to detail
• Adaptable to change
• Contribute beyond self to the learning and growth of others

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