• US Shift 
• Experience: 4+ years  
• Working Days: Monday to Friday (5 Days)
• Shift Timing: 8:30 PM to 5:30 AM IST

Job 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, with 5+ years of QA experience
• Strong knowledge of US FDA regulation such as 21 CFR, 210, 211, 820 and other regulatory standards
• Fluency in English; as well as strong and organizational skills
• Must have a laptop/ PC and good Internet connectivity.