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.