Technical Supervisor

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 the cleaning activity through three bucket system 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, 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 the cleaning and operation of glove port integrity tester and record the documents.
To perform the 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 perfòrm filter integrity of hydrophobic/ hydrophilic and disk filters as per routine and production

To perform cleaning and operation of vial capping machine and maintain the record.
To maintain proper status label of area and equipment as per SOP.
To check the calibration schedule of all measuring instruments and inform to supervisor.
To inform for updation of the calibration schedule of all measuring instruments and maintain the same.
To record and ensure 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 and ensure plant wise cGMP compliance.
To handle additional responsibility assigned by HOD.