Operator

Major Purpose of the Job :Responsible for small volume injection manufacturing related activities.Principal Task and Responsibilities : 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 perform area cleaning as per SOP and maintain records. To perform cleaning and operation of Mfg./Holding vessels as per SOP and maintain record. 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.