Specialist in Quality Regulatory Operations – Sandoz
About Company:
Sandoz, a leader in the generic and biosimilar medicines sector, reached almost 500 million patients last year. We are proud of this achievement and aim to do more!
Job Details:
| Position | Quality Operations (GQS I) |
|---|---|
| Organization | Sandoz |
| Location | India |
| Salary | ₹8.7 Lakhs to ₹15.0 Lakhs per annum |
| Qualifications | B.Pharm, M.Pharm, MSc, BSc, MBA |
| Experience | 4 years in Quality Regulatory Operations |
Position Name: Quality Operations (GQS I)
Organization: Sandoz
Location: India
Salary: ₹8.7 Lakhs to ₹15.0 Lakhs per annum
Qualifications:
- B.Pharm, M.Pharm, MSc, BSc, MBA
Experience Required:
- 4 years in Quality Regulatory Operations
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 Assessments (QRA) for suppliers/service providers
- Manage supplier/material qualification and related documentation
- Prepare regulatory statements for materials and finished products
- Manage and archive Quality Questionnaires, QAA, QRA, and compliance documents
- Adhere to GxP and compliance requirements of Sandoz
- Perform Quality Operations supporting product quality compliance and regulatory workflows
- Support service quality and process improvement projects, including CAPA management
- Communicate with customers and partners to gather feedback on support services
- Ensure proper execution of service deliverables through workflow applications (SAP, GxQEM, CONDOR, ESOPs, TrackWise)
- Address GxP and non-GxP issues promptly and ensure compliance with procedures
How to Apply:
If you are interested in this opportunity, please share your updated resume.