Position Name: Quality Assurance Specialist
Company Name: Sandoz
About Sandoz:
Sandoz is a global leader in generic and biosimilar medicines, impacting almost 500 million patients last year. Our open, collaborative culture drives our talented and ambitious colleagues, offering agile and flexible-hybrid careers with personal growth opportunities. Join us to shape the future of accessible, high-quality medicines.
Department: Not specified
Qualification:
- Pharmacy/Science/MBA/Engineering or equivalent from a reputed institute
Experience:
- Minimum 4 years in Quality Assurance, Regulatory, or pharmaceutical manufacturing (drug substances/products/medical devices)
- GxP knowledge, basic IT knowledge
- Experience working closely with global stakeholders
Job Location: Not specified
E-Mail: Not provided
Key Responsibilities:
- Draft Annual Monitoring and Certification reports for materials.
- Draft and archive Quality Assurance Agreements with suppliers/service providers.
- Evaluate and manage Supplier Change Notifications (SCN).
- Perform Quality Risk Assessment (QRA) for existing and new suppliers/service providers.
- Manage supplier/material qualification and supplier-related documentation.
- Prepare regulatory statements for materials and finished products.
- Manage and archive Quality Questionnaires, QAA, QRA, and Compliance (ASL, Oversight monitoring) for Country Quality.
- Adhere to current GxP and compliance requirements, ensuring product quality compliance and regulatory workflows.
- Support service quality and process improvement projects, CAPA management within GQSI.
- Communicate regularly with customers and partners for feedback on support services and report deliverables.
- Hold accounts in workflow applications (SAP, GxQEM, CONDOR, ESOPs, TrackWise) to ensure service deliverables.
- Intensify service-related GxP and non-GxP issues, ensuring timely investigation and compliance.
Essential Requirements:
Languages:
- Proficient in English (written and spoken).
- Good communication, presentation, and interpersonal skills.
Benefits:
- Flexible working
- Learning and development opportunities
