Pharmaceutical Complaints Management Specialist

3 days ago

Navi Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 28,00,000
Complaints Management Specialist

The primary focus of this role is to ensure that complaints are handled effectively and efficiently, ensuring that the company's quality standards are met.

  • Responsibilities include receiving and reviewing initiated complaints in the QMS tool, processing and sending technical complaints to Contract Manufacturing Organizations or suppliers for investigation.
  • Coordinate with stakeholders to obtain complaint sample availability and additional information from Country Organizations (CO) as required.
  • Periodically follow up on complaints with suppliers to ensure timely investigations.
  • Perform queries in QMS tools like GxQEM as per established procedures.
  • Review supplier investigations and complete them in the QMS tool for complaints delegated to this role.
  • Act as a QA approver for complaints delegated to this role.
  • Track and extend complaint/actions as needed. Complete assigned tasks according to business requirements.
  • Manage child records such as investigation and communication actions as necessary.
  • Participate in meetings/discussions between sites and suppliers regarding supplier complaints when required.
  • Conduct quarterly complaint/deviation trending and reporting. Evaluate signals and manage in the QMS tool.
Requirements
  • Education: Pharmacy/Science/MBA/Engineering or equivalent from a reputable institution.
  • Languages: Fluent English (written and spoken).
  • Skills: Good communication, presentation, and interpersonal skills.
  • Experience:
    • Minimum 7 years of experience in Quality Assurance, Regulatory or pharmaceutical drug substances/products/medical devices manufacturing.
    • GxP knowledge and basic IT knowledge.
    • Experience working closely with global stakeholders.
What You'll Bring to the Role

You will bring a strong background in Quality Assurance, regulatory compliance, and excellent communication skills to this role.

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