Senior Quality Assurance Specialist
3 weeks ago
About Us
Teva Pharmaceuticals is a leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio, we offer over 350 API products and support 80% of top 50 global pharmaceutical companies. Our company has a reliable history dating back over 80 years, making us one of the most trusted API suppliers.
Our Success Story
- We employ over 4,000 professionals at 14 sites worldwide, with state-of-the-art production facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India.
- Our significant investment in R&D generates a steady flow of APIs, allowing for timely introduction of new products to market.
Your Role
This Senior Quality Assurance Specialist position plays a critical role in ensuring the quality and compliance of our API manufacturing processes. Key responsibilities include:
- Tracking and tracing application for product licenses with government bodies.
- Developing Quality Technical Agreements with contract laboratories, material suppliers, customers, or service providers.
- Executing internal audits and cGMP walks as per approved schedules.
- Tracking and tracing internal audits, cGMP walks, CGMP GEMBA, and Self-Inspections.
- Tracking CAPA triggered from internal audits, cGMP walks, CGMP GEMBA, Self-Inspections, customer audits, or regulatory audits.
- Preparing customer and regulatory audit responses and reviewing internal audit reports.
- Maintaining inspection readiness documents, including monthly updates on List of QMS, List of rejections, List of reprocess, and List of material distribution.
- Preparing monthly quality council presentations.
- Closely monitoring quality KPIs and participating in the Quality Council.
- Updating site master files and maintaining various licenses up-to-date.
Your Qualifications
To be successful in this role, you will require:
- A minimum of 8 years of experience in Quality Assurance or a related field.
- A Master's degree in Chemistry or a related field (preferable).
Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment and welcomes applications from diverse candidates.
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