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 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 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 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.