Senior Quality Operations Specialist

4 days ago

Navi Mumbai, Maharashtra, India beBeeQuality Full time ₹ 15,00,000 - ₹ 28,00,000
Job Description

Quality Operations Specialist Role

We are seeking a highly skilled Quality Operations Specialist to join our team. As a Quality Operations Specialist, you will play a critical role in ensuring the quality of our products and services.

  • Complaints Management: Receive and review initiated complaints in our QMS tool. Process technical complaints for investigation with CMO/Supplier.
  • Coordinate complaint sample availability and additional information exchange between Country Organization (CO) and CMO as required.
  • Periodically 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 QMS tool for delegated complaints.
  • Serve as QA approver for delegated complaints.
  • Track and extend complaint/actions as per requirements.
  • Manage child records such as Investigation, Communication action, etc., as required.
  • Participate in site-supplier meetings/discussions over supplier complaints as needed.
  • Perform quarterly complaint/deviation trending and reporting. Evaluate signals and manage further in QMS tool.

Required Skills and Qualifications

To succeed in this role, you should possess:

  • Education: Pharmacy/Science/MBA/Engineering/equivalent from a reputable institute.
  • Languages: Fluency in English (written and spoken).
  • Communication/Presentation/Interpersonal skills: Strong ability to communicate effectively.
  • Experience: Minimum 7 years in Quality Assurance, Regulatory, or pharmaceutical manufacturing.
  • GxP knowledge/Basics IT knowledge: Familiarity with industry regulations and software applications.
  • Global stakeholder experience: Proven ability to work closely with international teams.

Benefits

This role offers:

  • Opportunities for career growth and development.
  • A collaborative and dynamic work environment.

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