Job Description

oTo follow safety rules in the premises according to the company norms. oResponsible to perform the CIP & SIP and VLT of lyophilizer oParticipating in Lyo loading & unloading the activities oResponsible to perform the in process checks during operation. oTo ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule oResponsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities. oResponsible for timely completion of calibrations and validations in coordination with engineering and QA related to Lyophilization and area. oTo maintain the BMRs and other log books in the Lyophilization area as per cGMP and SOP. oPreparation and periodic revision of SOPs related to area. oResponsible for the operation and cleaning of lyophilizer area. oCleaning and sanitization of Lyophilization area drain points. oResponsible to carry out the lyophilization area operations as per the SOP and BMR. oOperation and cleaning of glove integrity and filter integrity testers. oResponsible for Dispensing, checking and receiving of PPM from warehouse on need basis. oPreparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. oResponsible for cleaning and storage of all the filling machine accessories and change parts. oOperation and cleaning of table mounted LAF and Ceiling mounted LAF oOperation and cleaning of steam sterilizer and HPHV steam sterilizer. oPreparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. oResponsible for monthly frequency activity. oResponsible for ensuring garments washing, drying and folding activities oResponsible for line clearance before start of the Activity. oTimely completion of SOP's training and on the job trainings related to Lyophilization area , Component preparation and sterilization area (Autoclave area). oMonitoring of DP, RH and temperature area in their Component preparation and sterilization area (Autoclave area). oResponsible for operation Maintenance and cleaning of Component preparation and sterilization area. oTo maintain the BMRs and other log books in the Component preparation and sterilization area (Autoclave area) as per cGMP and SOP. oPreparation and periodic revision of SOPs related to Component preparation and sterilization area (Autoclave area). oCleaning and sanitization of drain points in Component preparation and sterilization area (Autoclave area). oOperation and cleaning of dynamic pass box in Component preparation and sterilization area (Autoclave area) oResponsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for the day to day activities. oResponsible for timely completion of calibrations and validations in coordination with Eng. and QA related to Component preparation and sterilization area (Autoclave area). oActivities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD's instructions and guidance.



Bachelor of Science / Degree with min. 5 years experience in Lyo