Officer, Lyophilization

•To follow safety rules in the premises according to the company norms. •Responsible to perform the CIP & SIP and VLT of lyophilizer •Participating in Lyo loading & unloading the activities •Responsible to perform the in process checks during operation. •To ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule •Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities. •Responsible for timely completion of calibrations and validations in coordination with engineering and QA related to Lyophilization and area. •To maintain the BMRs and other log books in the Lyophilization area as per cGMP and SOP. •Preparation and periodic revision of SOPs related to area. •Responsible for the operation and cleaning of lyophilizer area. •Cleaning and sanitization of Lyophilization area drain points. •Responsible to carry out the lyophilization area operations as per the SOP and BMR. •Operation and cleaning of glove integrity and filter integrity testers. •Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. •Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. •Responsible for cleaning and storage of all the filling machine accessories and change parts. •Operation and cleaning of table mounted LAF and Ceiling mounted LAF •Operation and cleaning of 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 monthly frequency activity. •Responsible for ensuring garments washing, drying and folding activities •Responsible for line clearance before start of the Activity. •Timely completion of SOP’s training and on the job trainings related to Lyophilization area , Component preparation and sterilization area (Autoclave area). •Monitoring of DP, RH and temperature area in their Component preparation and sterilization area (Autoclave area). •Responsible for operation Maintenance and cleaning of Component preparation and sterilization area. •To maintain the BMRs and other log books in the Component preparation and sterilization area (Autoclave area) as per cGMP and SOP. •Preparation and periodic revision of SOPs related to Component preparation and sterilization area (Autoclave area). •Cleaning and sanitization of drain points in Component preparation and sterilization area (Autoclave area). •Operation and cleaning of dynamic pass box in Component preparation and sterilization area (Autoclave area) •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 in coordination with Eng. and QA related to Component preparation and sterilization area (Autoclave area). •Activities 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