Sr. Specialist - Quality Services (Product Complaints)

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 via Cross functional teams (Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Regulatory, Legal, Field Alert Reporting, risk management departments, etc.) (as applicable) for complaint management. Conduct management of complaints into the proper database (as applicable) and perform assessment, ensuring timely processing as per defined scope. Focus on operational tasks within the complaint handling process.
• 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 to ensure all the data necessary for complaint investigation process. 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. Periodically prepare Key Performance Indicators (KPIs) data for meetings. Support on additional continuous improvement & team initiatives/projects. Create/Review the inquiry, Translate to English (As applicable). Determine if the inquiry is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation, customer service or Field Alert Reporting-related information (as applicable). Ensure respective teams are communicated, if required. Follow up with the complainant for additional information and complaint sample management (as applicable).
• Appropriate handling, review and closure (as applicable) of information considered as Non-PTC. Capture and document sample information into the proper fields of the system (as applicable) Ensure to complete all the required information. Health authority called-in complaints, prioritized complaints, and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Ensure acknowledgement of Complaint (as applicable). Communicate with the complainant for any other request/ additional information related to complaint, if required.
• Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Categorize Product Technical Complaint (PTC) based on its potential impact on product quality or patient safety as per defined timelines. Recording of complaint details in global system including defective quantity / verify lot number. Categorize and process the Fast track complaint based on defined criteria. Sample management- request for sample collection, update sample/picture information in global system.
• 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 complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Maintain compliance with all relevant regulatory requirements for complaint management and reporting.

About you:

• Experience: Minimum of 5 years of related experience in the pharmaceutical industry. Experience of working on manufacturing sites is an added advantage.
• Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience working on manufacturing sites is an added advantage.
• Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment.
• Education: Bachelor's or Masters in Life Sciences/Healthcare/Pharmaceutical science
• Languages: Excellent knowledge of English language (spoken and written).