Officer, Autoclave
Officer, Autoclave
Amneal PharmaceuticalsThis job is no longer accepting applications
Job Description
Description
JOB DESCRIPTION
QUALIFICATIONS
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
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 1 year or more in 1 - 4 Years
More Info
Key Skills
Lipid extruder
Heating cooling skid
Heating magnetic stirrer with thermometer
Air shower
Table mounted LAF
HAWO pouch sealer
Strip chart recorder
Ceiling mounted LAF
BMRs
Fogger
SART system
Filter integrity tester
Sonicator
TFF
Compounding isolator
Manufacturing and filtration vessels
About Company
Skills:
Ms Excel, Data Cleaning, Data Analysis, SurveyCTO, Stata, statistical software, App-based data collection tools, Data quality monitoring, Sampling techniques
Skills:
GMP SOP Compliance, Deviation Handling, process monitoring, Team Supervision, Pharmaceutical Production, BMR Documentation
Skills:
Operation and cleaning of dynamic pass box, Packing, Operation and cleaning of visual inspection table, Operation of Lux meter, Bopp taping machine with weighing balance, PFS packing area machines, Visual Inspection, Track and trace system