Job Title: Quality Sr Specialist
Location: Gwalior, India, 477117
Company: Teva Pharmaceuticals
Job ID: 59011
Who We Are
Teva Pharmaceuticals is the leading international supplier of active pharmaceutical ingredients (APIs). With over 350 API products, we are the trusted global supplier for the majority of top pharmaceutical companies. TAPI has been a reliable name in the generic API industry for over 80 years, providing innovation and exceptional customer service. With a strong presence across 14 sites worldwide, our production facilities in India and other locations drive the development of new and effective products to meet global healthcare needs.
How You’ll Spend Your Day
Tracking and Tracing Licenses:
Manage the tracking and tracing of applications for product licenses with government bodies to ensure compliance and regulatory adherence.
Quality Technical Agreements:
Develop and manage Quality Technical Agreements (QTAs) with approved contract laboratories, material suppliers, customers, and service providers to ensure quality standards are met.
Audit and cGMP Walks:
Execute internal audits and cGMP (current Good Manufacturing Practices) walks in accordance with the approved schedule.
Track and monitor audit outcomes, including CAPAs (Corrective and Preventive Actions) from internal audits, customer audits, and regulatory inspections.
Audit Responses and Reports:
Prepare responses for customer and regulatory audits and ensure the review of internal audit reports to address findings and ensure compliance.
Inspection Readiness:
Maintain documents related to inspection readiness, including monthly updates on critical QMS (Quality Management System) lists, rejections, reprocessing, and material distribution.
Quality Council Contributions:
Contribute to the Quality Council by closely monitoring quality KPIs and assisting with monthly presentations and reporting.
Site Master File and License Maintenance:
Keep the site master file updated and ensure various licenses are maintained, ensuring regulatory compliance at all times.
Your Experience and Qualifications
Experience:
At least 8 years of experience in the pharmaceutical industry, with a strong background in quality systems and compliance.
Qualification:
M.Sc. in Chemistry (preferred).
Teva’s Equal Employment Opportunity Commitment
Teva is committed to promoting diversity and inclusion in the workplace. We offer equal employment opportunities to all individuals, regardless of age, race, religion, gender, or other protected characteristics. If you are contacted for an interview, please let us know if you need any accommodations to assist you during the recruitment process.
If you're a seasoned quality professional with a strong understanding of quality systems and regulatory requirements, we invite you to apply for this exciting opportunity with Teva Pharmaceuticals.
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