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Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to clean room procedures that align with CGMP practices or guidelines
Cleans the equipment in the clean room daily
ensures equipment validations are up to date
Follows the tech check tech process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation
Takes inventory in the clean room to identify components needed to fill production batches, as scheduled
Ensures all components entering the clean room are sterile
Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products
communicates within the clean room, from room to room
Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs
Prepares and sterilizes components/vials for appropriate solutions
sterilizes solutions and fills into specified containers
Validates that garbing standards have been followed on a semi-annual basis
Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months
Follows standard operation procedures to package sterile products in their final container closure
Designate people and hoods for different tasks
Uses appropriate process to establish sterility on products received via pass through from compounding
Clock in and out for every scheduled shift in a timely manner
Requirements:
Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, and behaving according to cleanroom procedures that align with CGMP practices or guidelines
Cleans the equipment in the cleanroom daily
ensures equipment validations are up to date
Follows the tech check tech process to oversee the techniques and practices of co-workers, including product assembly, measurements, garbing, sterile techniques, and documentation
Takes inventory in the cleanroom to identify components needed to fill production batches, as scheduled
Ensures all components entering the clean room are sterile
Coordinates and communicates with compounding and vial wash to obtain supplies needed to turn products
communicates within the clean room, from room to room
Documents batch records, Climents (measurements of air in the room), lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs
Prepares and sterilizes components/vials for appropriate solutions
sterilizes solutions and fills into specified containers
Validates that garbing standards have been followed on a semi-annual basis
Completes 3 consecutive media fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months
Follows standard operation procedures to package sterile products in their final container closure
Designate people and hoods for different tasks
Uses appropriate process to establish sterility on products received via pass through from compounding
Clock in and out for every scheduled shift in a timely manner