Teva Dir Quality Expert 

Malaysia, Penang, George Town 

47888458

• Support the Implementation of the Site Inspection Readiness Program
• Input, Review and Approval of Complex Investigations ( OOS, Deviations, Incidents, etc.)
• End to End Process Support for Health Authority Inspections
• Support the Implementation of Quality Risk Management
• Review and Monitor Quality Improvement Plans
• Prepare, Evaluate, and identify risks and discuss site Performance Data at TAPI Quality Council
• Train Site Colleagues on the Corporate Standard System
• Support Global Quality Compliance Initiatives
• Data Reliability assessments, gap evaluations, GxP data mapping
• Global change control committee management, Global Nitrosamines committee management
• Cross contamination strategy implementation at sites
• Review global TAPI policies and standards and provide inputs

• Degree in Chemistry, Biology, Microbiology, Pharmacy or similar demonstrated knowledge in cGXP regulations.
• 15+ years' experience in GMP environment, continuous professional development 10+ years' experience in managerial tasks, to lead a quality department or organization Exposure to International working environment
• Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation etc.
  

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