Intern - Product Complaint Manufacturing & Supply Services
Core
Handle Product Technical Complaints (PTCs) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards and facilitating accurate interpretation/translation of complaints.
Role type
Product Complaint Manufacturing & Supply Services Intern
Builds
Operational complaint handling processes and regulatory compliance documentation
Domain
Healthcare / Pharmaceutical / Medical Devices
Deliverable
client delivery
Required skills
Proficiency in Mandarin, Regulatory compliance knowledge, Cross-functional collaboration, Data management, Quality Management System (QMS) adherence, GxP documentation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Handle Product Technical Complaints (PTCs) for medical devices, pharmaceutical products, biologics, and combination products; Facilitate accurate interpretation and translation of PTCs received from respective countries; Collaborate with internal/external stakeholders (Manufacturing sites, Customer Service, Medical Information, Pharmacovigivance, Regulatory, Legal, Field Alert Reporting, risk management) for complaint management; Conduct management of complaints into the proper database and perform assessment; Ensure compliance of documentation and all Quality processes according to applicable regulations/Sanofi standards; Handle Quality Management system (QMS) records by applying data privacy regulations; Document Hub-related GxP activities; Act as a Regional hub for assigned countries regarding complaint follow-up and sample management; Determine if inquiries are associated with Adverse Events, Pharmacovigilance (PV) Special Situations, customer service, or Field Alert Reporting; Handle Health authority called-in complaints, prioritized complaints, and suspected counterfeit complaints with urgency; Capture and document sample information into the proper fields of the system; Forward complaints to Global Hub including translation if applicable.
