JOB PURPOSE:

To perform pharmaceutical microbiological procedures in compliance with USP, WHO regulations and other regulatory/audit groups to ensure the accuracy of test results and raw data generated.

Responsibilities:

• P erform Environmental monitoring sampling and samples preparation
• Reading & recording Result of EM sample
• Start Lab investigation for OOS and OOT Results
• Arrange Media stock to be prepared according to production plan.
• Water analysis
• Bioburden test
• Identification of Microorganism using gram stain & advanced identification system
• Raw material sampling
• Growth promotion Test
• Perform Microbial limit test for Raw & Finished product
• Perform Bacterial Endotoxin test for Raw material & Finished product
• Label claim assay for any lysate new Lot
• Handling biological Indicator
• Media Fill inspection
• Disinfectant Efficacy test
• Monitor compressed air
• Sanitize Sterility room
• Perform Sterility Test
• Perform Gown Qualification trials
• Executes validation studies, prepares summary reports and change controls in order to keep management informed.
• Prepares laboratory records while maintaining accuracy, completeness, compliance and conformance to specifications in order to be ready for both internal and external audits.
  
  
  

QUALIFICATIONS, EXPERIENCE, & SKILLS:

Minimum Qualifications:

Bachelor’s degree in science or pharmacy.

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