Complaint Investigator - Product Quality

**• Manage the receiving and handling (documentation, coordination, investigation, resolution, {replacement/reimbursement 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 Drug/Device combination product and Medical Device product and provide report to management.• Gather data to assist with any potential recall and/or 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.**• Bachelor's Degree plus minimum 2 years of Quality Assurance experience in the pharmaceutical and/or 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: 2025-02-19