Quality Assurance Coordinator

7 days ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000
Job Overview

This role involves managing and coordinating Quality Assurance activities to ensure compliance with regulatory requirements. The position requires strong analytical and communication skills to work effectively with cross-functional teams.

Key Responsibilities:
  1. Receive and review initiated complaints in the QMS tool, process/send technical complaints to CMO/SUPPLIER for investigation.
  2. Coordinate complaint sample availability, additional information from Country Organization (CO) to CMO/Contract Manufacturing Organization and vice versa as required.
  3. Periodically follow up on complaints with suppliers for timely investigation, perform queries in QMS tools like GxQEM according to procedures.
  4. Review supplier investigations and complete them in QMS tool for complaints delegated to GQSI, act as QA approver for complaints delegated to GQSI.
  5. Track and extend complaint/actions as per requirements, complete assigned tasks as per business needs.
  6. Manage Child records such as Investigation, Communication action etc. as per requirement.
  7. Participate in meetings/discussions between sites/suppliers over supplier complaints as needed.
  8. Perform Quarterly complaint/deviation trending and reporting, evaluation of signals and further management in QMS tool.
Requirements:
  • Education: Pharmacy/Science/MBA/Engineering/equivalent from a reputable institute.
  • Languages: Fluent in English (written/spoken), good communication, presentation, and interpersonal skills.
  • Experience: Minimum 7 years in Quality Assurance, Regulatory or pharmaceutical drug substances/products/medical devices manufacturing, GxP knowledge, basic IT knowledge, experience working closely with global stakeholders.
Benefits

This role offers a chance to work in a dynamic environment with opportunities for professional growth and development.

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