Officer, Lyophilization

Job Description

• 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.

Qualifications

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

Skills Required

lyophilization, Cgmp