Sr. Specialist Quality Services (Product Complaints)

Job Description

Job title: 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 Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. null Show more Show less