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Executive, autoclave

Early Applicant
  • Posted 9 days ago
  • Be among the first 10 applicants

Job Description

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 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.

Education

QUALIFICATIONS

  • Bachelors Degree (BA/BS) B. Sc. - Required
  • Master Degree (MS/MA) M. Sc.. - Preferred

Experience:

  • 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

More Info

Job Type:
Industry:
Employment Type:

Job ID: 152705825

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