Description
Position Summary:
A professional responsible for monitoring physical characteristics, sampling, verification in manufacturing processes, quality control, and waste management.
Key Responsibilities:
1. Quality monitoring in manufacturing and packaging processes
2. Sampling and analysis of intermediate and finished products
3. Verification and release of areas and products for manufacturing
• Monitor physical characteristics of samples during manufacturing and packaging processes
• Sample intermediate products, bulk products, and finished products for routine analysis or stability studies of pharmaceuticals, followed by submission to the quality control laboratory for physicochemical, instrumental, and microbiological analysis
• Perform container-closure integrity testing on manufactured products
• Verify and release areas prior to initiating manufacturing processes
• Verify warehouse inventory allocations
• Reconcile material losses based on manufacturing orders
• Verify manufacturing stages
• Monitor in-process controls for manufacturing, primary packaging, and secondary packaging
• Verify finished products prior to shipment to customers
• Approve or reject products as required, based on product checklists
• Execute quarantine, sampling, approved, and rejected labeling
• Prepare certificates of analysis for analyzed entities (printed materials)
• Conduct physical tests on printed materials
• Participate in product validation and technology transfer
• Ensure proper handling and disposal of hazardous waste generated in the area
• Execute activities of the Quality Management System (QMS)
Other Requirements
Bachelor's degree in Pharmaceutical Chemistry and Biology (QFB), Pharmacy (QF), Industrial Pharmacy (IQ), or Industrial Chemistry (QI); professional license and degree certificate (in process)