- Develop and implement quality management strategy for Validation and Calibration processes.
- Develop and maintain systems to establish standards relating to activities and production processes.
- Participating in GMP Projects:
- Checking & approving the site validation review plans for:
- Building.
- HVAC system.
- Services.
- Equipment.
- Ensuring that all validation activities and documentation are complying with the recommendations of validation master plan.
- Follow up and participate in change control system.
- Preparing of Validation Master Plans(VMP),Performance Qualification Protocols(PQPs) and Validation reports(VR) for different validation activities such as:
- Process validation.
- Validation Review for whole activities.
- Process Equipment qualification.
- Facility qualification.
- CSV and software Validation.
- Shipping and receiving:
- Makes sure that the car temperature is measured during charging or receiving
- Makes sure that the product is compacted, in a standard way
- Makes sure that one product is entered into the receiving area, to ensure no mistakes occurred
- Make sure to place each patch separately, as the patches are not mixed
- Checks the products during receivings and shipment, and makes sure of their safety, production date, operation number and isolation of damaged quantities and transferred to the area under examination.
- Ensure that the car is clean and that there is no hole in it
- Reviewing the returns , mention the reason for the return, and sign the document
- Follow-up the printing process:
- Make sure the clean room is clean before the printing process starts
- Review The quantity sent to be printed
- Review The data of the message to be printed
- Monitor The product and the printing process is completed
- Confirm the requested data for the product to be printed
- Follow up the Car Cleaning:
- Make sure the car is clean inside and out
- Ensure that there is no light perforation inside the car
- Ensure that there is no odor in the vehicle
- Make sure that there is no sharp object inside the car
- Follow-up installations and equipment:
- Ensure that there is no malfunction with the air conditioning machine
- Make sure there are no malfunctions in the dukat or the store floor
- Make sure that there are no malfunctions with the electric lights
- Make sure that there are no lightning strikes
- It is ensured that there is no malfunction with the drain pipes
- Make sure that there is no water leak
- Follow up the stock:
- Verify the presence of a label on each pallet
- Ensure that the pallet is properly housed
- The pallet is verified at the place specified for it
- ensured that there are no open cartons on the pallet
- ensured that the pallet is wrapped with a stretch and the appearance of the stretch is good
- Make sure that no product is placed on the floor
- Emphasis is placed on following the rules and the work system inside the store according to (SOP
Bachelor's degree in Pharmaceutical Science 2 Years of experience in the pharmaceutical company.Good command of English both written and spoken.Computer skills (Word, Excel & PowerPoint).Decision-making, inter-personnel relationships, and leadership skills.Communication skills and team working spirit.