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.
- 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.
- 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.
- Proactively identify areas for improvement and support the implementation.




- Ensure the documentation of Hub related GxP activities.
- Abide any other responsibilities as assigned/ aligned by manager.
- Prepare and update data (timeline quality KPIs) periodically for team meetings.

To support team initiative/continuous improvement projects.
Receipt of inquiry/complaint classify/categorize the complaint based on its potential impact on product quality or patient safety as per defined timelines.
Act as a regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management.
Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable).
Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site.
Ensure completion of the investigation. Perform final review/update the compl

📌 Senior Specialist Quality Services (Secunderabad)
🏢 Sanofi
📍 Secunderabad