23 Aug
|
Amneal Pharmaceuticals
|
Hyderabad
23 Aug
Amneal Pharmaceuticals
Hyderabad
Essential Functions
JOB DESCRIPTION
- 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 Positive 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 filtrati
📌 Executive, autoclave (Hyderabad)
🏢 Amneal Pharmaceuticals
📍 Hyderabad