About this role
To maintain proper hygienic condition before entering to manufacturing area.
To follow manufacturing area entry exit procedure properly.
To take part in training whenever necessary.
Preparation of Disinfectant solution as per SOP.
To perform cleaning activity through three bucket system as per SOP
To perform cleaning and operation of vial washing machine Dehydrogenation tunnel and maintain
the record.
To perform cleaning and operation of vial filling machine, lyophilized automatic loading/unloading
system and maintain the record.
To perform on line in-process checks as per SOP.
To perform area cleaning as per SOP and maintain records.
To perform cleaning and operation of glove port integrity tester and record the document.
?To perform Particle count monitoring in grade A and grade B area.
To perform cleaning, operation and load preparation of autoclave as per routine and production plan
•To perform filter integrity of hydrophilic/hydrophobic and disk filters as per routine and production
plan
•To perform particle monitoring as per routine and production plan.
To perform cleaning and operation of vial capping machine and maintain the record.
To perform proper status labeling of area and equipment as per SOP
To check calibration schedule of all measuring instruments and inform to supervisor
To record TEMP/RH in the mfg. aseptic and processing areas.
To take part in equipment qualification activities.
To inform supervisor if any deviation from approved process.
To follow Good documentation practice during documentation.
To maintain area and equipment logs as per SOP
To follow plant wise cGMP compliance.
To handle additional responsibility assigned by HOD.
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