
Quality Operations Specialist
19 hours ago
This role plays a critical part in ensuring product quality compliance and regulatory processes are executed efficiently.
- The Quality Operations Specialist will deliver high-quality services to support product quality compliance and regulatory workflows.
- The individual will manage accounts in workflow applications to ensure timely execution of service deliverables.
- Reports in various applications will be generated and analyzed, with follow-up actions taken as required.
- Service-related GxP and non-GxP issues will be escalated, investigated, and addressed promptly.
- Data extraction from relevant sources in Novartis tools/applications.
- Compilation of external supplier APQR and/or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
- Contributory reports for product-related evaluations will be collected.
- Support in updating and maintenance of APQR schedule.
- Maintenance of MAH/BRS review schedule.
- Coordination with NCQ SPoCs and/or manufacturing/packaging/testing/batch releasing sites as required to draft MAH/BRS checklist.
- Data extraction from relevant sources as applicable and compilation of MAH/BRS in a predefined format.
- M.Pharm/MBA/Engineering/equivalent degree from a reputable institution.
- A minimum of 1 year experience in Quality Assurance, Regulatory or pharmaceutical industry.
- Familiarity with GxP compliance requirements.
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