Website Sanofi ltd
Post Name: Sr. Specialist Quality Services (Product Complaints)
Location: Hyderabad
About the job:
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.
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
