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Amneal Pharmaceuticals

Assistant Manager, QMS

Amneal Pharmaceuticals
Ahmedabad, India
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  • Posted 15 hours ago
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Job Description

Job Description

  • Manage and investigate product quality complaints received from the market in line with pharma regulations and Amneal's established procedure.
  • Perform detailed analysis of complaints and conduct root cause investigations using appropriate quality tools and prepare Report.
  • Coordinate with cross-functional teams (Quality Assurance, Manufacturing, Regulatory, etc.) for effective resolution and investigation of complaint,
  • Ensure timely closure of complaints as per defined timelines and regulatory requirements. Maintain accurate, complete, and audit-ready documentation of all complaints and investigations.
  • Monitor, track, and trend complaint data to identify recurring issues and potential risks. Support continuous improvement initiatives to enhance product quality, safety, and compliance.
  • Contribute to improving patient safety and customer satisfaction through effective complaint handling.
  • Ensure full compliance with company SOPs, GMP guidelines, and regulatory standards (e.g., FDA, EMA).

Technical Skills

  • Strong analytical and problem-solving skills with a structured approach to investigations

In-depth knowledge of investigation methodologies and root cause analysis tools (e.g., CAPA, Fishbone, 5 Whys)

  • Good understanding of pharma guidelines related to complaint handling and investigations (GMP, regulatory requirements)
  • Excellent attention to detail with strong documentation and report-writing skills
  • Effective communication and cross-functional coordination abilities
  • Ability to assess risk, identify trends, and make data-driven decisions
  • Critical thinking and decision-making skills for accurate and compliant investigation outcomes.

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Pharmaceutical
Employment Type:
Full time

Job ID: 147213977

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Last Updated: 12-05-2026 03:27:41 AM
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