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. To ensure and perform the Preparation and filtration of disinfectant solution as per SOP. To ensure and perform the cleaning activity through three bucket system as per SOP. To ensure and perform cleaning and operation of vial washing machine/ Dehydrogenation tunnel and maintain the record. To perform and ensure the cleaning and operation of vial filling machine, Lyophilized automatic loading/unloading system and maintain the record. To perform and ensure on line in-process checks as per SOP. To perform and ensure area cleaning as per SOP and maintain records. To perform and ensure the cleaning and operation of glove port integrity tester and record the documents. To perform and ensure the particle count monitoring in Grade-A and Grade-B area. To perform and ensure cleaning, operation and load preparation of autoclave as per routine and production plan.
To perform and ensure filter integrity of hydrophobic/ hydrophilic and disk filters as per routine and production plan. To perform and ensure cleaning and operation of vial capping machine and maintain the record. To maintain proper status label of area and equipment as per SOP. To inform for updation of the calibration schedule of all measuring instruments and maintain the same. To record and ensure 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 Positive Documentation Practices (GDP) during documentation. To maintain area and equipment logs as per SOP. To follow and ensure plant wise cGMP compliance. To handle additional responsibility assigned by HOD.