Job Description
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 filtration solution as per SOP.
To perform cleaning and operation of vial washing machine/ Depyrogenation tunnel and maintain the record.
To perform the cleaning and operation of vial filling machine, Lyophilizer automatic loading/unloading system and maintain the record.
To perform on line in-process checks as per SOP.
To perform area cleaning through three bucket systelïl as per SOP and maintain records.
To perform the cleaning and operation of glove port integrity tester and record the documents.
To perform the 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 hydrophobic/ hydrophilic and disk filters as per routine and production
To perfòrm clean ing and operation of vial capping machine and maintain the record.
To maintain proper status label of area and equipment as the SOP
To check the calibration schedule of all measuring instruments and inform to supervisor.
To record the Temperature/ Relative Humidity/ Differential Pressure in manufacturing, aseptic and processing areas.
To take part in equipment/ area qualification activities.
To inform supervisor if any deviation from approved procedure/ process.
To follow Good Documentation Practices (GDP) during documentation.
To maintain area and equipment logs as per SOP.
To follow plant wise cGMP compliance.
To handle additional responsibility assigned by HOD.
