Executive Autoclave

Amneal Pharmaceuticals; Hyderabad; On-site; INR 350,000 - 550,000; Full time

Job summary

Amneal Pharmaceuticals in Hyderabad, India seeks an Autoclave Operator to ensure sterile manufacturing compliance with cGMP and GMP standards. You will operate and maintain autoclave equipment, execute CIP/SIP, monitor parameters, document batch records, and support process improvements.

The role requires strict adherence to regulatory requirements (FDA/EMA) and cleanroom practices, with responsibility for cleaning and area equipment in autoclave zones.

Qualifications

• GMP/cGMP knowledge for sterile manufacturing
• Bare minimum understanding of regulatory requirements and FDA/EMA guidelines
• Strong documentation and batch record-keeping skills
• Solid cleanroom practices and aseptic handling
• Awareness of process improvement opportunities

Responsibilities

• Operate autoclave equipment and associated sterilization apparatus in compliance with SOPs and GMP requirements
• Support sterilization cycle operations including loading, unloading, and monitoring autoclave processes to meet product specifications
• Perform general maintenance on autoclave equipment to ensure readiness
• Follow SOPs to meet cGMP requirements for sterile manufacturing
• Maintain accurate batch documentation in compliance with regulatory/internal requirements
• Ensure tasks comply with FDA and EMA guidelines
• Participate in process improvement projects to enhance quality, cost efficiency, and scheduling
• Conduct area cleaning and sanitization per cleanroom and aseptic GMP standards
• Operate and clean dynamic pass box in autoclave area
• CIP & SIP of vessels related to autoclave area
• Operate and clean area equipment in autoclave zone such as pass boxes, glove cleaning and integrity testers
• Prepare, filter, and issue disinfectants and deactivation solutions for production areas
• Operate and clean LAF tables (table mounted and ceiling mounted) and steam sterilizers
• Prepare loads for autoclaving (garments, disinfectant, filling, filtration, stoppers, seals) per validated patterns
• Maintain and clean Component preparation and sterilization area
• Clean and sanitize drain points in autoclave area
• Monitor DP, RH and temperature in compounding and filtration areas
• Coordinate calibrations and validations related to autoclave area with Eng/QA

Skills

GMP knowledge

cGMP compliance

Documentation skills

Cleanroom discipline

Regulatory awareness

Job description

Job Description

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.