Specialist Quality Services (Product Complaints) 

Job titleSpecialist, 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:

• Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements Evaluate complaints for severity and risk, ensuring timely review and processing. Focus on operational tasks within the compliant handling process. 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.

• Conduct management of complaints into the proper database (as applicable) and perform assessment, ensuring timely processing as per defined scope. Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan. Participate in ad-hoc meetings for product-specific complaint issues and provide timely feedback on complaint investigations.

• Ensure the compliance of documentation and all Quality processes according to applicable regulations/ Sanofi standards. Handle Quality Management system (QMS) records by applying data privacy regulations, manage any discrepancies, and ensure completion within defined timelines.

• Ensure the documentation of Hub-related GxP activities. Proactively identify areas for improvement and support on the implementation. Abide any other responsibilities as assigned/aligned by manager. Act as Investigator Leader/Investigator for all products complaints and perform the investigation as per applicable procedure. Coordinate with sites, EMS entities & any other stakeholders for complaint investigation related activities as applicable.

• Communicate with the complaint officer for any additional information related to Product technical complaint and complaint sample. To perform batch genealogy & recurrency check for complaints. Assign investigation request to the appropriate CMO (Contract Manufacturing organization). Coordinate for sending complaint sample to CMOs as required.

• 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. To escalate or notify the EM&S entity/management in case of any significant event related to complaint investigation, as applicable. To support EMS entities for complaint management as per the requirement.

• Participate in periodic monitoring of KPI (Key Performance Indicators) and the compliance of KPI.

About you:

• Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. 1 - 3 years of related experience in the pharmaceutical industry.

• Should be knowledgeable in Quality functions of pharmaceutical industry. Analytical skills and ability to multitask in a stressful environment.

• Excellent knowledge of English language (spoken and written)

• Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner.

• Stretch to go beyond the level we have operated at up until now. Act in the interest of our patients and customers. Act instead of waiting to be told what to do. Put the interests of the organization ahead of my own or those of our team.

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.