Ahmadabad, Gujarat, India
Posted: May 15, 2025
On-siteFull-time
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Job Description
  • Handle and distribute various samples received for microbiological analysis; maintain the related logbook.

  • Maintain housekeeping and cleanliness of the Microbiology laboratory.

  • Maintain inventory of microbiological media; perform media preparation, growth promotion tests, and reconciliation.

  • Handle microbial cultures and perform inoculum preparation.

  • Conduct water sampling and analysis as per the defined schedule; complete all associated records and reports.

  • Perform sterility testing, bacterial endotoxin testing, antibiotic microbial assay, and bioburden testing of raw materials, in-process materials, and finished products.

  • Carry out environmental monitoring and non-viable particle monitoring of microbiology cleanroom areas.

  • Identify and log environmental monitoring isolates.

  • Conduct disinfectant efficacy testing and microbial identification as per schedule and SOPs.

  • Handle and test biological indicators.

  • Perform Container Closure Integrity Testing (CCIT) of post-media fill units.

  • Observe microbial plates and media fill units exposed in the manufacturing area.

  • Report any out-of-specification (OOS) results or deviations to the department in-charge.

  • Prepare standard operating procedures (SOPs) for microbiology-related activities.

  • Coordinate with manufacturing, engineering, and QC teams for qualification, validation, and re-qualification activities.

  • Participate in qualification activities of manufacturing and microbiology areas.

  • Monitor and test compressed air, nitrogen gas, and perform personnel monitoring.

  • Prepare material/product indents as per requirements.

  • Initiate and review change controls, OOS investigations, and deviations.

  • Complete self-training records and maintain documentation.

  • Prepare laboratory study protocols.

  • Review instrument logbooks, raw data of raw materials, packing materials, in-process samples, finished products, and water samples.

  • Prepare Certificates of Analysis (COA).

  • Follow good laboratory practices (GLP) and safety protocols.

  • Perform water analysis and maintain daily water trend reports.

  • Sample, test, and release raw materials, packing materials, miscellaneous materials, and in-process samples; maintain reserve samples as per SOP.

  • Update instrument logbooks and record data in laboratory notebooks or relevant software.

  • Plan and monitor cleaning, sterilization, and depyrogenation of glassware and microbiological items.

  • Maintain status labels, logs, and reconciliation records for all laboratory items.

  • Handle and maintain pure microbial cultures.

  • Record daily area readings such as temperature, humidity, differential pressure, and cleaning logs.


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Additional Info
Min. Experience
-
Job Location Type
On-site
Job Type
Full-time
Predicted Seniority Level
-
Job Duration
-
Language(s)
-
Est. Budget/Pay Rate
To be discussed
Est. hrs
-
Optimal Job Start
-
Job Industry
-
Job Function
-
Employer
Amneal Pharmaceuticals
Preferred Applicant Countries
Global
Job Ref
J25D73F44B7DA
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