Executive, autoclave
About this role
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 Good 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.
•Responsible for timely completion of calibrations and validations activity in coordination with Engineering
and QA related to autoclave area.
Company at a glance
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
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