Job Description
To follow the safety rules in the premises according to the company norms.
- 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 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 Dispensing, checking and receiving of the Raw Material from warehouse.
- Timely completion of SOPs training and on the job trainings related to autoclave area.
- Responsible for Area cleaning and Maintain the area properly for autoclave area.
- Responsible for operation and cleaning of dynamic pass box in autoclave area.
- To carry out CIP & SIP of the vessels related to autoclave area.
- Responsible for timely completion of calibrations and validations activity in coordination with Engineering
and QA related to 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.
- Operation and cleaning of dynamic pass box in Component preparation and sterilization area (Autoclave
area).
Cleaning and sanitization of drain points in Component preparation and sterilization area (Autoclave
area).
- Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the
production area.
- Monitoring of DP, RH and temperature in compounding and filtration area, autoclave area
Qualifications
Qualification - B.Pharmacy, B.SC
