To follow the safety rules in the premises according to the company norms.
•Timely completion of SOPs training and on the job trainings related to compounding and filtration area.
•Monitoring of DP, RH and temperature in compounding and filtration area.
•To maintain online the BMRs and other log books in the respective area as per cGMP and SOP.
•Responsible for Area cleaning and Maintain the area properly for compounding and filtration area.
•Responsible for operation and cleaning of agile pass box in compounding and filtration area.
•Responsible for Cleaning and sanitization of drain points in compounding and filtration area.
•To carry out CIP & SIP of the vessels related to compounding and filtration area.
•Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR.
•Responsible to perform the in process checks during operation.
•Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and conductivity meter, Compounding isolator,
Manufacturing and filtration vessels, Heating & cooling skid, Air shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder, HAWO pouch sealer.
•Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for the day to day activities.
•Responsible for timely completion of calibrations and validations activity in coordination with Engineering and QA related to compounding and filtration area.
•Responsible for cleaning and operation of filtration vessel for powder process and aseptic filtration & evaporaton for powder process.
•Responsible for cleaning and storage of all the Manufacturing equipments accessories and change parts.