Quality Assurance Specialist
4 weeks ago
TAPI, a leading international supplier of active pharmaceutical ingredients (APIs), boasts a portfolio of over 350 API products. With an impressive history dating back over 80 years, the company has established itself as a trusted supplier, supporting 80% of top 50 global pharmaceutical companies.
About the RoleWe are seeking a highly skilled Senior Quality Manager to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the highest standards of quality and compliance.
Job Description- Track and trace applications for product licenses with government bodies
- Develop and execute Quality Technical Agreements with approved contract laboratories, material suppliers, customers, or other service providers
- Conduct internal audits and cGMP walks according to approved schedules
- Monitor and track internal audit, cGMP walk, CGMP GEMBA, and Self-Inspection activities
- Manage CAPA triggered from internal audit, cGMP walk, cGMP GEMBA, Self-Inspection, customer audit, or regulatory audit
- Prepare customer and regulatory audit responses and review internal audit reports
- Maintain inspection readiness documents, including monthly updates on List of QMS, list of rejections, list of reprocess, and list of material distribution
- Prepare monthly quality council presentations
- Closely monitor quality KPIs and participate in the Quality Council
- Update site master files and maintain various licenses up-to-date
To be successful in this role, you should have:
- A minimum of 8+ years of experience in a similar position
- A Master's degree in Chemistry (preferred)
The estimated salary for this position is around $120,000 - $150,000 per year, depending on location and experience.
Work EnvironmentTeva Pharmaceuticals is committed to creating a diverse and inclusive work environment. We welcome applicants from all backgrounds and perspectives.
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