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 Valuable 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.