Company Overview:
Vieco Pharmaceuticals is a pharmaceutical factory in JAFZA Dubai for the production of solid (Tablets and Capsules), Liquid (Syrups) and semi-solid (Ointments and Creams) pharmaceutical products.
Job Responsibilities:
- Support in developing and maintaining Quality Management System activities.
- Provide quality oversight for the production areas (manufacturing and packaging) and the warehouse.
- Ensure continuous shop floor presence, pre-operational inspection, sampling of products and in-process checks.
- Provide online supervision of batch dispensing/manufacturing/packaging operations to ensure that:
- Dispensed raw materials or packaging materials have been verified for identity and quantity before using any of them in the manufacturing processes.
- All rooms, main equipment and containers are correctly identified and cleaned.
- Line clearance, pre-operational checks and challenge tests have been performed according to batch record and relevant SOPs.
- Steps of manufacturing processes are recorded according to Good Documentation Practice.
- Steps of manufacturing processes have been performed according to cGMP regulations and internal procedures.
- Process parameters have been followed as described in the Batch Record.
- IPC tests required are performed correctly on time and recorded in relevant documents.
- Rejected in-process materials are identified and controlled.
- Ensure that effective systems are in place for the following:
- Handling of rejected/recalled products
- Control of batch records
- Material/Product waste destruction.
- Trial materials handling.
- Line clearance and cleaning.
- Sampling of product.
- Environmental Monitoring
- Dispatch of finished products
- Report any observed incidents during routine production, support in Root Cause Analysis [RCA] with the responsible area owner and agree/follow up on its corrective and preventive action.
- Create/Review all IPC SOPs.
- Review the batch manufacturing and packaging records to ensure proper completion and overall compliance.
- Participate in Process/Cleaning/Hold time validation studies.
- In use check of CAPAs arising from investigations and audit findings to confirm that all identified actions are in use, and CAPA effectiveness check to ensure that the actions assigned are effective to prevent the recurrence of the same failure/ finding.
- Archive and maintain the released batch records in the documentation room.
- Familiar with Amplelogic & SAP electronic systems