
Website Sanofi ltd
Post Name: Sr. Specialist Quality Services (Product Complaints)
Main responsibilities:
Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
Collaborate with internal/external stakeholders viz Cross functional teams, Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management, Contract manufacturing organization.
Enter complaints into the global database and evaluate complaints for severity and risk, ensure timely processing and closure of the complaints.
Manages and ensures the compliance of all Quality processes and documentation with applicable regulations/ Sanofi standards. Handle QMS records & any discrepancies and ensure completion within defined timelines.
Ensure investigation management and coordination with internal and external partners (including tracking and monitoring of investigations). Review & closure of investigation reports to ensure correctness, completeness, and adherence to standards including root cause analysis, CAPA, assessment and prioritization.
Collection, visualization & analysis of complaint data. Preparation of trend reports of complaints related to products, sites, EMS & Countries defined as per procedure.
About you:
Experience: 3 – 7 Years Experience.
Education: Graduate in Pharmacy or life sciences or Engineering or Biotechnology.
Languages: English, Hindi is preferred