Operations Quality Control Manager

6 days ago

Mumbai, Maharashtra, India beBeeQuality Full time

Job Overview

The role of Quality Operations Specialist (GQS I) entails managing complaints from initiation to closure. Key responsibilities include coordinating with suppliers, reviewing investigations, and performing QA approval tasks.

This position requires strong organizational skills, attention to detail, and effective communication abilities.

  • Main Accountabilities:
  • Receive and review initiated complaints in the QMS tool. Send technical complaints to CMO/Supplier for investigation.
  • Coordinate complaint sample availability, additional information from Country Organization (CO) to CMO (Contract Manufacturing Organization) and vice versa as needed.
  • Periodic follow-up on complaints with suppliers for timely investigation. Perform queries in QMS tools like GxQEM according to procedures.
  • Review supplier investigations and complete them in the QMS tool for complaints delegated to GQSI. Serve as QA approver for complaints delegated to GQSI.
  • Track and extend complaint/actions as per requirements. Complete assigned tasks based on business needs.
  • Manage child records such as Investigation, Communication action etc. as per requirement.
  • Participate in meetings/discussions between sites and suppliers over supplier complaints as needed.
  • Perform quarterly complaint/deviation trending and reporting. Evaluate signals and further management in the QMS tool.
  • Key Requirements:
  • Education: Pharmacy/Science/MBA/Engineering/equivalent from a reputable institute.
  • Languages:
  • Fluent in English (written and spoken)
  • Good communication, presentation, and interpersonal skills
  • Experience:
  • Minimum 7 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/products/medical devices
  • GxP knowledge, Basic IT knowledge
  • Experience working closely with global stakeholders

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