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Associate Analyst - Quality Operations
Novartis India
Hyderabad, IND
Full-time
Entry
Onsite
Discovered 1 weeks ago
Annual Product Quality Reviews (APQR)Country Quality ReviewsQuality operationsQuality data extraction and compilationProduct quality data interpretationQuality documentation review
Free
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Annual Product Quality Reviews (APQR)Country Quality ReviewsQuality operations
Role Overview
Supports Annual Product Quality Reviews by extracting, interpreting, compiling, and reviewing quality information.
Drafts conclusions for product quality reviews using data from suppliers and internal Novartis systems.
Key Skills for This Role
Annual Product Quality Reviews (APQR)Country Quality ReviewsQuality operationsQuality data extraction and compilationProduct quality data interpretationQuality documentation review
Full Job Posting
Role Overview
Supports Annual Product Quality Reviews by extracting, interpreting, compiling, and reviewing quality information.
Drafts conclusions for product quality reviews using data from suppliers and internal Novartis systems.
APQR Responsibilities
- Collect contributory reports for product-related evaluations and coordinate with suppliers or manufacturing sites.
- Maintain APQR schedules and review reports and data for completeness and correctness.
- Complete APQRs within defined timelines and archive approved APQRs.
- Communicate approved supplier APQRs and related documents to QOP.
- Track APQR volume distribution through approval and update approved data in e-compass.
- Interpret APQR data to conclude product robustness.
Country Quality Reviews
- Support the Country Quality Review schedule and coordinate with NCQ SPOCs and relevant operational sites.
- Extract, compile, interpret, and consolidate data in predefined Country Quality Review formats.
- Review information for accuracy and completeness and submit finalized reviews for approval.
- Archive approved Country Quality Review documents as applicable.
Desirable Requirements
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