About this role
Major Purpose of the Job :
Responsible for small volume injection manufacturing related activities.
• To take part in lyophilized related activities as per SOP.
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 take part in preparation and filtration of disinfectant solution as per SOP.
• To perform cleaning, operation and load preparation of autoclave as per routine and production plan.
• To perform the cleaning activity as per SOP.
• To perform cleaning and operation of vial washing machine/ Dehydrogenation tunnel and maintain the record.
• To perform the cleaning and operation of vial filling machine, manufacturing, filtration, Lyophilized automatic loading/ unloading system and vial capping machine 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 filter integrity of hydrophobic/ hydrophilic and disk filters as per routine and production plan.
• To maintain proper status label of area and equipment as per SOP.
• 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.
Any other jobs assigned from time to time.