Operational Excellence Specialist

1 day ago


Navi Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 18,50,000 - ₹ 21,50,000
Quality Assurance Specialist - Compliance and Governance

This role involves managing complaints and deviations within the quality management system, ensuring adherence to regulatory requirements and maintaining a culture of excellence.


About the Job:

We seek a highly skilled Quality Operations Specialist to join our team. As a key member of the quality assurance team, you will be responsible for:

  • Receiving and reviewing initiated complaints in the QMS tool, and processing technical complaints for investigation;
  • Coordinating complaint sample availability and additional information from Country Organization to Contract Manufacturing Organization and vice versa as needed;
  • Periodically following up on complaints with suppliers for timely investigation;
  • Performing queries in QMS tools like GxQEM according to procedures;
  • Reviewing supplier investigations and completing them in the QMS tool for complaints delegated to GQSI;
  • Acting as QA approver for complaints delegated to GQSI;
  • Tracking and extending complaint/actions as per requirements;
  • Managing child records such as Investigation, Communication action etc. according to requirements;
  • Participating in meetings/discussions between sites and suppliers over supplier complaints as needed;
  • Performing quarterly complaint/deviation trending and reporting, evaluating signals and further management in the QMS tool.

Requirements:

To succeed in this role, you must possess:

  • A strong background in quality assurance, regulatory affairs, or pharmaceutical manufacturing;
  • Excellent communication, presentation, and interpersonal skills;
  • Minimum 7 years of experience in Quality Assurance, Regulatory, or pharmaceutical manufacturing;
  • GxP knowledge and basic IT knowledge;
  • Experience working closely with global stakeholders.

You'll Bring:

Your expertise in quality assurance, regulatory compliance, and teamwork will enable you to excel in this role.



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