Job
Description
To follow the safety rules in the premises according to the company norms. To ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule. To maintain online the BMRs and other log books in the respective area as per cGMP and SOP. 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 Dispensing, checking and receiving of the Raw Material from warehouse. Responsible for Area cleaning and Maintain the area properly for autoclave area. Responsible for operation and cleaning of area equipment present in the autoclave area like Pass boxes, Glove cleaning and integrity testers. Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. Operation and cleaning of table mounted LAF and Ceiling mounted LAF and steam sterilizer and HPHV steam sterilizer Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. Responsible for Maintenance and cleaning of Component preparation and sterilization area (Autoclave area). To maintain the BMRs and other log books in the Component preparation and sterilization area (Autoclave area) as per cGMP and SOP. Monitoring of DP, RH and temperature in compounding and filtration area, autoclave area. 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. Timely completion of SOPs training and on the job trainings related to autoclave area and filling area. Responsible for operation and cleaning of dynamic pass box in autoclave area and filling area. To carry out CIP & SIP of the vessels related to autoclave area and filling area. Responsible for timely completion of calibrations and validations activity in coordination with Engineering and QA related to autoclave area and filling area. Preparation and periodic revision of SOPs related to aseptic processing area. Responsible to perform the in process checks during filling.
