To ensure that Viaflex filling lines are set up per SOP 16-08-06-046 and SOP 16-06-19-055
Perform Line Clearances at the Tank Room and Filling Rooms.
Performs Tank Hook-up and Machine set-up, at start-up and at batch change.
Flush Filling lines and filling machines per SOP.
Set-up Volumes per Standard Operating Procedure.
Perform minor maintenance of machines.
Ensure availability of solvent and material in the filling room.
Perform and document Cleaning and sanitisation of area per relevant SOP.
Assist in other departmental needs on a daily basis.
Perform In process checks during the filling of the batch.
Ensure correct samples and procedures are followed in the production area.
Conduct filling of Viaflex products.
Maintain GMP and GDP standards throughout manufacturing processes.
Report breakdowns in the filling area.
Ensure Production area free of material from previous batches.
Filling machine connected to the correct Tank.
Machines flushed per Standard Operating Procedure, thus preventing dilution of the batch with other Solution or Distilled Water.
Machines which have been set-up correctly without defective Cup-Seal, 'O'-Rings, Filters, Turbine, Valve Cylinders, Stripper and Seals.
Alcohol prepared daily. Cyclohexanone applicators filled and correctly identified.
Facility, Equipment, Filters and related areas are to be cleaned and sanitised per the current SOP 16-06-19-055 and Viaflex SOP 16-08-06-046
Grade 12 or equivalent
1 to 2 years' experience in pharmaceutical industry.
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