Validation & Calibration Supervisor
Jazeera pharmaceutical Industries (JPI) (FDA Approved) (Member of Hikma Pharmaceuticals PLC)
- Ensure that the work is performed in full compliance with GMPs, FDA and jazeera safety standard
- Contribution in scale up of batches, process enhancement, and technology transfer and to bring reduction in product cost.
- Handling of troubleshooting of machines& process related problems.
- Preparing & Implement IQ/OO/PQ protocols for machines and building management system, HVAC system.
- Evaluating of the actions needed to re-qualify any machines, lines and systems when
a maintenance requisition form, a transferring form or a change control is submitted to the
validation department (especially for deionizer water system, plant machines and HVAC system)
- Checking of the plants and buildings drawings.
- Generating the machine master file (MMF) which including the history of machines and all related technical documents with all changes might be happened.
- Coordinate to apply the machine, system and lines site acceptance test (SAT) with manufacturers’ and suppliers experts (with German Bosch Company, American IPS Company& England MANESTY Company).
- Evaluating the preventive maintenance needed for machines, Lines, system and water treatment plant and it’s related units
- Controlling the water feeding and returns closed circulation system and evaluating the loops by testing the water through inlet/outlet lines of pla
- Have the final approval for all machines, lines, systems. And verify systems and units that have to be qualified.
- Implement DOP testing for all HEPA Filters for Horizontal Laminar Air Flows, Sampling/Weighing Booths and Clean Booths across the plant.
- Handling calibration activities and results
- Handling performing calibration for all balances in all plants
- Performing qualification for all temperature and humidity ( Mapping Study) & preparing reports