Complaint Investigator - Product Quality

Responsibilities: • Manage the receiving and handling (documentation, coordination, investigation, resolution, {replacementreimbursement} and closeout) of all Product Quality Complaints in timely manner that complies with requirements and Regulatory requirements (21CFR Parts 210, 211, 820). • Manage Complaint Sample retrieval. • Follow-up with Complainant (Patient, Sales Reps, Hospitals, Pharmacies and Physicians etc.) to obtain applicable information pertaining to reported events. • Review completed complaint files to assure proper documentation, coordination, investigation, resolution, and closeout and ensure compliance to regulatory requirements • Review contact center calls to ensure proper triage and documentation. Provide feedback to management if any discrepancy is found. • Monitor complaints for product trends and notify management of events requiring immediate Action. As applicable conduct trend investigation. • Generate monthly and quarterly PQC metrics for all products and provide report to management and present in meetings. • Generate Risk Management metrics for DrugDevice combination product and Medical Device product and provide report to management. • Gather data to assist with any potential recall andor reporting actions. • Manage reconciliation processes in coordination with other teams (call center, Pharmacovigilance, and medical information etc.) to ensure it meets procedure requirement and timely completion. • Support, manage and complete assigned projects in accordance with requirements. • Support Internal GMP audit and External Regulatory inspections. Requirements: • Bachelor's Degree plus minimum 2 years of Quality Assurance experience in the pharmaceutical andor medical device industry • Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820) specifically those applicable to complaint handling, investigations, and documentation • Excellent analytical, problem solving, and troubleshooting skills. • Proficient in MS Office software and TrackWise

Created: 2025-02-21