Sanofi
ManufacturingandServicesSeniorSpecialistQualityServicesProductComplaintsKLHub
Neural analysis suggests this role is
optimal for Senior candidates.
“Manufacturing and Services Senior Specialist Quality Services Product Complaints KL Hub at Sanofi. Skills: Product Complaints, Quality Services, Korean Language. Handle product technical complaints. Process product technical complaints”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
1-2 Years experience, Korean Speaker
What You'll Do.
Handle product technical complaints
Process product technical complaints
Ensure accurate documentation
Complete training timely
Coordinate with stakeholders
Investigate complaints
Manage urgent regulatory cases
Ensure compliant closure
Conduct management of complaints
Ensure timely processing
Participate in ad-hoc meetings
Provide timely feedback
Ensure documentation compliance
Ensure completion within timelines
Document Hub-related GxP activities
Identify areas for improvement
Support implementation of improvements
Follow up with complainant
Manage complaint sample
Determine inquiry type
Communicate with respective teams
Handle Non-PTC information
Close Non-PTC information
Capture sample information
Document sample information
Complete required information
Forward complaint to Global Hub
Handle health authority complaints
Handle prioritized complaints
Handle suspected counterfeit complaints
Ensure acknowledgement of Complaint
Communicate with complainant for requests
Communicate for additional information
Maintain compliance with regulatory requirements
Manage complaint reporting
How You'll Work.
Team & Collaboration
Cross functional teams; Regional stakeholders; Global stakeholders; Manufacturing sites; Customer Service; Medical Information; Pharmacovigilance; Regulatory departments; Legal departments; Field Alert Reporting; Risk management departments
Full Job Description
**Job title** : _Manufacturing and Services Senior Specialist Quality Services Product Complaints KL Hub_ * _Location: Petaling Jaya, Malaysia_. * _Hiring Manager: M &S Services, Lead Quality Services - Product Complaints, KL Hub._ _About the job_ Handle and process product technical complaints in compliance with regulatory, QMS, and GxP requirements, ensuring accurate documentation and timely training completion. Use Korean language expertise to translate and assess complaints while coordinating with cross functional and regional/global stakeholders for investigation and resolution. Act as a regional hub by triaging complaints, managing urgent regulatory cases, engaging complainants, and ensuring compliant closure or escalation. **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. **Main responsibilities:** Core responsibilities: 1\. Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. 2\. Proficient in Korean, facilitating the accurate interpretation and translation of Product Technical Complaints (PTCs) received from the respective countries. 3\. 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. 4\. 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 p
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