Responsibilities:
- Completes the intake process of complaints through phone and email into the Complaint Intake Systems which includes translations from local language to English when required, the 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.
- Communication and cooperation with customers and distributors involved in the reported complaints
- Internal communication and cooperation with relevant local or global stakeholders in other departments involved with complaints management within the organization, like affiliate CQA, Medical Information, Regulatory Affairs and Pharmacovigilance
- Supports more complex complaints that are escalated
- Serve as a Subject Matter Expert for a designated product(s) within the team when required
- Where applicable, decide whether a replacement, credit, or warranty claim is warranted, and notify the appropriate stakeholders to complete the process. OR complete activities to process the replacement, credit or warranty activities for the customer.
- Where applicable, partner with affiliate CQA for translation or communication support when needed
- Support management with any documentation or SOP reviews when needed
- Partner with other departments to address queries/inquiries e.g. Medical Info, Regulatory, PV
- Support management with any projects / process improvement initiatives
- Support management during audits and inspections
- Where applicable, make vigilance reporting decisions and prepare the relevant vigilance reports for submission to MOH.
- Where applicable, translate vigilance reports into local language for submission to MOH
Qualifications and Skills:
- High school diploma or equivalent required. College or a 2-year Associate Degree is preferred
- Experience in a Quality environment or customer service support role, preferably in a healthcare setting
- Strong attention to detail, critical thinking, and can work independently with minimal direction
- High quality customer service skills
- Ability to express ideas clearly in both written and oral communications
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
- Computer skills and ability to navigate through software systems
- Strong prioritization and time management skills
- A fairly good command of the English
