Expert Specialist-Product Complaint Quality

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This role is to be responsible for all Product Complaint activities related to Lilly products marketed in China and Asia-Pacific regions (ASEAN), work with various business parties to ensure case reporting and solve in a timely manner; and APRC China Satellite Regional Center activities. This position is based in Kuala Lumpur, Malaysia.

China Affiliate RCP (Responsible Complaint Person) – Product Complaint

• Complaint Initiation, Follow-up, and Closure
• Collect the complaint data as required from Lilly China Answer Center, various business parties, and Lilly employees, etc. The complaint includes sources from China and Asia-Pacific regions (ASEAN).
• Identify the classification of report as a Product Complaint (PC), Adverse Event (AE), combined PC&AE, or inquiry according to Lilly defined criteria.
• Accurately translate written PC and/or PC associated with AE information from Mandarin to English.
• Case entry of translated information into Product Complaint electronic database.
• Confirmation of receipt of any reports from third party organizations.
• Follow up with Chinese reporters in terms of additional data collection and complaint sample retrieval request etc.
• Work closely with Patient Safety, APRC and local/global cross-functional teams to handle complaint related activities or issues.
• Monitor the case overdue status and ensure the incidents can be closed on time to meet Lilly requirements.
• Complaint response (verbal or written format) to reporters based on the initial request.
• Support suspect reporting of Lilly products.
• Identify and escalate potential urgent reports to quality leadership.
• Complaint Monitoring, Trending, and Process/SOP maintenance
• Conduct periodic reconciliation of AE/PC events with Lilly internal/external business partners to ensure the timely case reporting and no missing PC cases.
• Develop and update PC related training or documents (e.g., local TRD) to support business.
• Periodic PC metrics consolidation, data mining and trending analysis report, to monitor the post-launch product complaint trends/incidents that may indicate a potential quality or patient safety issue.
  

APRC (Asia Pacific Regional Center) China Satellite Assessment and Analysis (pre-requisite of RCP experience and qualification)

• APRC China Satellite Regional Center Assessment
• Assess product complaint information appropriately. (e.g., designate an appropriate complaint level, assign suitable complaint and/or analysis category(ies).
• Determine the need for additional investigation and forward product complaint records to the proper manufacturing or packaging quality unit for further investigation, as required.
• Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from related parties.
• Determine the need for the product complaint sample.
• Review and evaluate complaint records for completeness and compliance with Global Quality Standards Product Complaints.
• Establish working relationships and influence outcomes with manufacturing/packaging sites that supply device (Humapen Ergo II) or medicine/device combination (Auto-injectors) to China to deliver timely complaint investigations.
• Work effectively within a team to deliver results in a defined timeline and manage the operation.
• Participate in departmental process improvement activities.
• Comply with local regulations at the site where the individual belongs to.
  

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