Sr. Specialist Quality Services (Product Complaints)

Job Description

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, we'll-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 we'llbeing benefits including high-quality healthcare, prevention, and we'llness 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 empowe'red to propose and implement innovative ideas.