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Specialist, Quality Operations
Novartis India
Hyderabad, IND
Full-time
Mid-Senior
Onsite
Discovered 1 weeks ago
Supplier quality managementQuality assurance agreementsSupplier qualificationQuality risk assessmentSupplier change notificationsRegulatory documentation
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Supplier quality managementQuality assurance agreementsSupplier qualification
Role Overview
This role is based in Hyderabad, India.
The Specialist, Quality Operations manages end-to-end supplier, vendor, and third-party quality activities.
Key Skills for This Role
Supplier quality managementQuality assurance agreementsSupplier qualificationQuality risk assessmentSupplier change notificationsRegulatory documentation
Full Job Posting
Role overview
This role is based in Hyderabad, India.
The Specialist, Quality Operations manages end-to-end supplier, vendor, and third-party quality activities.
Major accountabilities
- Draft annual monitoring and certification reports for incoming materials.
- Draft, negotiate where applicable, and archive quality assurance agreements with suppliers and service providers.
- Evaluate supplier change notifications and initiate quality records for applicable changes.
- Draft and evaluate supplier incoming material specifications.
- Perform quality risk assessments for existing and new suppliers and service providers.
- Manage supplier and material qualification and supplier-related documentation.
- Prepare regulatory statements for materials and finished products.
- Manage quality records and support service delivery teams with quality topics and third-party risk management.
- Coordinate supplier information management approvals for quality deliverables.
- Prepare reports for applicable annual product quality review sections.
- Evaluate supplier-related change controls and deviations.
- Coordinate discrepant material and supplier complaints, audit preparation, QARP, FURP, and CAPA management.
Obligatory requirements
- MPharm, BPharm, MSc, or an equivalent qualification from a reputed university.
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