Job Description

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

Technical Skills

1. 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)
2. Good understanding of pharma guidelines related to complaint handling and investigations (GMP, regulatory requirements)
3. Excellent attention to detail with strong documentation and report-writing skills
4. Effective communication and cross-functional coordination abilities
5. Ability to assess risk, identify trends, and make data-driven decisions
6. Critical thinking and decision-making skills for accurate and compliant investigation outcomes.