Complaint Resolution Officer
- Minimum 2 Years
- Work from Home
We are seeking a skilled and experienced FDA Regulatory Compliance Specialist. The successful candidate will be responsible for providing excellent customer service, ensuring that the Complaints Team resolve all complaints efficiently, effectively, in a timely manner.
Job Description:
- Shift: 8:30pm – 5:30am IST
- Working Days: 5 days (Mon-Fri)
- Experience: Minimum 2 years
- Location: Work from Home
Detailed Job Roles and Responsibilities
- The role involves managing complaints and ensuring quality standards within medical and pharmaceutical departments.
- Responsibilities include receiving and investigating complaints from consumers and CMOs via CRM platforms like NetSuite and SAP.
- The specialist will log complaints, conduct investigations to identify defects, and in next steps he/she will ensure proper communication with CMOs & prepare documentation for FDA investigation and audits. Documentation will include things like lot numbers, product details, allergic complaint etc.
- On an average, 20 complaints are received monthly, forwarded by CMOs and consumers both.
- Experience in handling manufacturing complaints in pharmaceutical and medical sectors with strict regulations is preferred.
- Strong communication skills are required to handle consumer calls and effectively communicate with CMOs.
- Attendance at FDA meetings and audits is non-negotiable, as it is a priority for the company.
Job Requirements
- Degree in the life sciences or equivalent qualification.
- Strong knowledge of US FDA regulation such as 21 CFR, 210, 211, 820 and other regulatory standards
- Fluency in English; as well as strong organizational skills
Must have a laptop/ PC and good Internet connectivity to perform these tasks from home
Apply for the Job:
Complaint Resolution Officer
- Minimum 2 Years
- Work from Home