Director Quality Expert
Mumbai, India, 400059
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
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
- 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.
Reports To
Teva API Quality Compliance Head
Teva’s Equal Employment Opportunity Commitment
TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market.