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Teva Director Quality Expert India, Uttar Pradesh 785937845
29.08.2024
The opportunity
- We are looking for a Director, Global Quality Compliance - TAPI.
- The main purpose of your job will be to ensure that the Quality Compliance System at TAPI sites is in place, securing compliance to operations, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will support manufacturing site remediation activities directly. You will also interact across the matrixed organization specifically with Manufacturing Science & Technology, Research & Development, Supply Chain Operations, Regulatory Affairs and other network manufacturing and supply sites.
- This role will ensure that each site receives the right level of support to sustain and continuously improve GMP compliance, to strategize the development and overall implementation of remedial plans, to solve quality-related compliance issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance with TAPI standards. Moreover, you will foster and develop onsite Quality culture across all sites.
How you’ll spend your day
- 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
Your experience and qualifications
- Master 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.
- Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, including US FDA, PMDA and ANVISA requirements
- Ability to understand and execute against TAPI Quality Management System
- Knowledge product types and manufacturing operations
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