Microbiologist

Key Responsibilities:

1. Bioburden Testing:

   
   
   • Perform bioburden tests on raw materials, in-process samples, and final products to determine microbial load.
   • Analyze and interpret bioburden data and prepare reports for quality assurance.

2. Bacterial Endotoxin Test (BET):

   
   
   • Conduct BET to assess endotoxin levels in pharmaceutical products and ensure compliance with regulatory standards.
   • Maintain and calibrate testing equipment as required.

3. Sterility Testing:

   
   
   • Execute sterility tests on pharmaceutical products according to established protocols and regulatory requirements.
   • Document and report results, addressing any deviations or non-conformances appropriately.

4. Environmental Monitoring:

   
   
   • Monitor environmental conditions in controlled areas, including temperature, humidity, and microbial counts.
   • Ensure compliance with environmental control standards and assist in investigations of deviations.

5. Sterility Assurance Knowledge:

   
   
   • Apply basic principles of sterility assurance in daily practices to uphold product integrity.
   • Assist in the development and implementation of sterility assurance protocols and practices.

• Bachelor’s degree in Microbiology, Biology, or a related field; advanced degree preferred.
• Strong knowledge of microbiological testing methods and regulatory requirements.
• Familiarity with Good Manufacturing Practices (GMP) and standard operating procedures (SOPs).
• Excellent analytical skills and attention to detail.
• Strong communication and teamwork abilities.