Quality Operations Specialist

19 hours ago


Hyderabad Warangal Nizamabad, India beBeeOperations Full time ₹ 9,00,000 - ₹ 14,00,000
Quality Operations Specialist Role

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.
Main Responsibilities:Product Quality Review
  • 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.
MAH/BRS Review Coordination
  • 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.
Ideal Candidate Profile:
  • 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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