Sr. Specialist-Product Complaint Quality

2 weeks ago

Petaling Jaya, Selangor, Malaysia Eli Lilly and Company Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

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
  1. Complaint Initiation, Follow-up, and Closure
    1. 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).
    2. Identify the classification of report as a Product Complaint (PC), Adverse Event (AE), combined PC&AE, or inquiry according to Lilly defined criteria.
    3. Accurately translate written PC and/or PC associated with AE information from Mandarin to English.
    4. Case entry of translated information into Product Complaint electronic database.
    5. Confirmation of receipt of any reports from third party organizations.
    6. Follow up with Chinese reporters in terms of additional data collection and complaint sample retrieval request etc.
    7. Work closely with Patient Safety, APRC and local/global cross-functional teams to handle complaint related activities or issues.
    8. Monitor the case overdue status and ensure the incidents can be closed on time to meet Lilly requirements.
    9. Complaint response (verbal or written format) to reporters based on the initial request.
    10. Support suspect reporting of Lilly products.
    11. Identify and escalate potential urgent reports to quality leadership.
  2. Complaint Monitoring, Trending, and Process/SOP maintenance
    1. Conduct periodic reconciliation of AE/PC events with Lilly internal/external business partners to ensure the timely case reporting and no missing PC cases.
    2. Develop and update PC related training or documents (e.g., local TRD) to support business.
    3. 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)
  1. APRC China Satellite Regional Center Assessment
    1. Assess product complaint information appropriately. (e.g., designate an appropriate complaint level, assign suitable complaint and/or analysis category(ies).
    2. Determine the need for additional investigation and forward product complaint records to the proper manufacturing or packaging quality unit for further investigation, as required.
    3. Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from related parties.
    4. Determine the need for the product complaint sample.
    5. Review and evaluate complaint records for completeness and compliance with Global Quality Standards Product Complaints.
    6. 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.
    7. Work effectively within a team to deliver results in a defined timeline and manage the operation.
    8. Participate in departmental process improvement activities.
    9. Comply with local regulations at the site where the individual belongs to.
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