Technical Assistant

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 the cleaning activity through three bucket system 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, Lyophilizcr 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 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 perf rm 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 perform cleaning and operation of vial capping machine and maintain the record. To maintain proper status label of area and equipment as per 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.