Senior Pharmaceutical Operations Specialist

3 days ago


Navi Mumbai, Maharashtra, India beBeeQuality Full time
Job Title

 

Key Responsibilities:
  • Manage and resolve complaints in a timely manner, ensuring that all necessary information is collected and communicated to relevant stakeholders.
  • Coordinate with suppliers to ensure complaint sample availability and additional information from country organizations as required.
  • Perform periodic follow-ups with suppliers for timely investigation and resolution of complaints.
  • Utilize QMS tools such as GxQEM to perform queries and review supplier investigations.
  • Act as QA approver for delegated complaints and manage child records accordingly.
  • Participate in meetings and discussions between sites and suppliers to address complaints as required.
  • Conduct quarterly complaint/deviation trending and reporting, evaluating signals and managing in QMS tool.

 

Requirements:
  • Pharmacy, Science, MBA, Engineering, or equivalent degree from a reputable institution.
  • Fluent English language skills (written and spoken).
  • Strong communication, presentation, and interpersonal skills.
  • At least 7 years of experience in Quality Assurance, Regulatory, or pharmaceutical manufacturing.
  • Basic IT knowledge and GxP expertise.
  • Proven ability to work collaboratively with global stakeholders.


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