Senior Specialist Quality Services - Product Complaints (Japanese Speaker)

Location:   Kuala Lumpur, Malaysia

Job Type: Full time, permanent

Work Arrangement: Hybrid

Core 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.

• Abide any other responsibilities as assigned/aligned by manager.

Other accountabilities

For MCCQ ☒

• 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.

• Consulting to FAR team in case of any filed alert expected (as applicable).

• Process Toll out manufacturing complaints in QualiPSO (Intake and closure) – As applicable.

Pursue progress , discover extraordinary

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