Specialist, Quality Services (Product Complaints)

Job title 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.
• Ensure to complete all training in a timely manner. Enter complaints into the global database and evaluate complaints for severity and risk, ensure timely processing and closure of the complaints. Participate in ad-hoc meetings for product-specific complaint issues and provide timely feedback on complaint investigations.
• Proactively identify areas for improvement and support the implementation. Ensure the documentation of Hub related GxP activities. Ensure to follow and adhere to safety rules & regulations as per Sanofi standards. Abide any other responsibilities as assigned/ aligned by manager. Ensure all QMS records are completed within defined timelines.
• Act as Investigator Leader for all Medical device and combination products complaints and perform the investigation as per applicable procedure. Comprehensive review of batch records, correlating relevant manufacturing data with quality events and deviations to elucidate reported defects.
• Follow-up and compliance with the specified deadlines for investigation and closure. Reclassification of PTC cases in the event, if necessary and consult with the responsible CO for additional information.
• Writing detailed investigation summaries in English, as required. Prepare periodic reports for MDQO on complaint activities and support during audits and regulatory inspections and perform quality checks on PTC activities.
• Ensure investigation of priority cases as quickly as possible.
  
  

About You

• Experience: 3 - 5 Years Experience.
• Education: Graduate in Pharmacy or Life Sciences or Engineering or Biotechnology.
• Languages: English 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.
  
  

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