Responsibilities:
1. Completes the intake process of complaints through phone and email into the Complaint Intake Systems, including translations from local language to English when required, initial identification of the complaint code, conducting follow-up activities for missing information, coordinating the logistics of complaint sample returns, and communicating the results of the complaint investigations when requested/required.
2. Communicates and cooperates with customers and distributors involved in the reported complaints.
3. Internal communication and cooperation with relevant local or global stakeholders in other departments involved with complaints management within the organization, such as affiliate CQA, Medical Information, Regulatory Affairs, and Pharmacovigilance.
4. Supports more complex complaints that are escalated.
5. Serves as a Subject Matter Expert for designated product(s) within the team when required.
6. Decides whether a replacement, credit, or warranty claim is warranted, and notifies the appropriate stakeholders to complete the process, or completes activities to process the replacement, credit, or warranty activities for the customer.
7. Partners with affiliate CQA for translation or communication support when needed.
8. Supports management with documentation or SOP reviews when needed.
9. Partners with other departments to address queries/inquiries, e.g., Medical Info, Regulatory, PV.
10. Supports management with projects/process improvement initiatives.
11. Supports management during audits and inspections.
12. Makes vigilance reporting decisions and prepares the relevant vigilance reports for submission to MOH when applicable.
13. Translates vigilance reports into the local language for submission to MOH when applicable.
Qualifications and Skills:
1. High school diploma or equivalent required; college or a 2-year Associate Degree preferred.
2. Experience in a Quality environment or customer service support role, preferably in a healthcare setting.
3. Strong attention to detail, critical thinking, and ability to work independently with minimal direction.
4. High-quality customer service skills.
5. Ability to express ideas clearly in both written and oral communications.
6. Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological, or device-related products.
7. Computer skills and ability to navigate through software systems.
8. Strong prioritizing and time management skills.
9. A fairly good command of English.
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