Key Responsibilities:
QMS & Complaint Management
- Initiate, investigate, review market complaints within the electronic Quality Management System (QMS).
- Perform periodic complaint trending and analysis to identify recurring patterns and risks.
- Support product recalls and mock recalls, including documentation, investigation, CAPA logging.
- Ensure timely closure of complaints, deviations investigation, CAPA actions and recall‑related records.
- Review investigation reports, supporting documents, and CAPA effectiveness.
Data Analysis, Trending & Dashboards
- Conduct trend analysis of complaints, defect categories, and closure performance.
- Handle and analyze QA datasets for QMR and regulatory reporting.
- Prepare monthly/quarterly dashboards using Excel / PPT (complaint rate, trends, aging, KPIs).
- Present inspection‑ready data summaries for management and compliance reviews.
- Tracking and maintaining the data base.
QMS Compliance & Documentation
- Perform QMS activities related to complaints and deviations management.
- Ensure documentation compliance with cGMP, GDP, and Data Integrity (ALCOA) principles.
- Support internal and external audits, including CAPA follow‑up.
- Assist in preparation, review, and maintenance of SOPs and QA documents.
- Complete and maintain all mandatory GxP trainings.
