A. GDP Quality Assurance – Healthcare Operations (primary accountability)
- QA oversight of receipt, storage, picking, packing, dispatch and returns of pharmaceutical products, including cold chain (2–8 °C / 15–25 °C); release/quarantine decisions, status labelling and segregation of quarantine, rejected, damaged, expired and recalled stock.
- Manage temperature excursions end to end — investigation, impact assessment, customer/MAH notification, disposition — and maintain excursion logs and trends.
- Cold chain governance: mapping protocols and reports, data logger deployment and download, alarm review, calibration status of monitoring instruments, shipper/passive packaging verification.
- Own deviations, non-conformances, CAPA, change control and quality risk management; drive root cause analysis and verify effectiveness before closure.
- Support qualification and validation (URS, IQ/OQ/PQ of chambers, equipment and utilities) and review engineering, pest control, cleaning, sanitation