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The Non-Combination Product Analyst III will be responsible for handling adverse events and E2E product quality complaint activities.
Job Responsibility:
Perform end-to-end complaint handling activities, including but not limited to Intake, triaging, recovery of field samples for evaluation, due diligence will be performed with complainant/intake centres/LOCs, trend analysis, defect coding, risk criticality assessment, holistic review and closure of investigations
Ensure that uniform and timely management of complaint records from receipt to closure, and investigations are accurately assessed for risk prioritization and performed per procedures, standards and regulations
Compile and analyse data, metrics and trends associated with complaint handling processes
Support internal and external audits and inspections
demonstrate ability to communicate regulatory and process positions as an SME during regulatory inspections.
Requirements:
2-3 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry
Bachelor's degree or master's degree (preferred) in technical, scientific, or engineering disciplines required.