Quality Expert

4 days ago

Hyderabad Warangal Nizamabad, India beBeeQuality Full time ₹ 14,00,000 - ₹ 17,00,000

**Quality Operations Expert Role Summary**

As a key member of our team, the Quality Operations Expert will play a vital role in ensuring product quality and compliance with regulatory requirements.

The ideal candidate for this position will possess strong analytical skills, attention to detail, and the ability to work effectively in a fast-paced environment.

Key Responsibilities:
  • Product Quality Compliance:
  • Ensure adherence to internal quality standards, relevant regulatory requirements, and filed product quality standards.
  • Quality Operations Services:
  • Perform and deliver quality operations services in support of product quality compliance and regulatory workflows.
  • Account Management:
  • Hold accounts in workflow applications to ensure appropriate execution of service deliverables.
  • Reporting and Analysis:
  • Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions if required.
  • Issue Escalation:
  • Evaluate and escalate service-related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
Annual Product Quality Review (APQR):
  • Extract data from relevant sources in Novartis tools/applications.
  • Interpret and compile external supplier APQR and/or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
  • Collect contributory reports for product-related evaluations.
  • Support in updating and maintenance of APQR schedule.
  • Perform review of APQR report/data as applicable to ensure it is complete and correct.
Marketing Authorization Holder (MAH) Review:
  • Support in maintenance of MAH/BRS review schedule.
  • Coordinate with NCQ SPoCs and/or manufacturing/packaging/testing/batch releasing sites as required to draft MAH/BRS checklist.
  • Extract data from relevant sources as applicable and compile MAH/BRS as per the requirements in a predefined format.
  • Interpretation and consolidation of the data.
  • Review for accuracy and completeness of compiled data/information.
Requirements for the Role:
  • M.Pharm/MBA/Engineering/equivalent from a reputed institute.
  • Minimum 1 year of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products/Medical device.
  • Basic awareness of GxP compliance requirements.

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