21 Aug
|
Amneal
|
Hyderabad
Essential Functions:
* Operate autoclave equipment and associated sterilization apparatus in
compliance with established SOPs and GMP requirements
* Support sterilization cycle operations including loading, unloading, and
monitoring of autoclave processes to meet product specifications
* Perform general maintenance on autoclave equipment and associated apparatus
as required to ensure operational readiness
* Execute standard operating procedures to meet current Valuable Manufacturing
Practices (cGMP) requirements for sterile manufacturing
* Maintain accurate batch documentation records in compliance with regulatory
and internal requirements
* Ensure all tasks are completed in full compliance with applicable regulatory
requirements including FDA and EMA guidelines
* Participate in process improvement projects to enhance quality, cost
efficiency, and production scheduling
* Conduct area cleaning and sanitization activities in accordance with
cleanroom and aseptic GMP standards.
* 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 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).
•Cleaning and sanitization of drain points in Component preparation and
sterilization area (Autoclave
area).
•Monitoring of DP, RH and temperature in compounding and filtration area,
autoclave area.
•Re
📌 Executive, autoclave (Hyderabad)
🏢 Amneal
📍 Hyderabad