Executive - QC Microbiology

Job Description

Responsibilities:

1. 
   

   Sterility and BET Testing:

   
   
   
   
   • Perform sterility and Bacterial Endotoxin Testing (BET) for raw materials and products.
   
   
   
   


2. 
   

   Validation Activities:

   
   
   
   
   • Execute validation activities.
   
   
   • Prepare and review Microbiology-related SOPs, STPs, validation protocols, and reports.
   
   
   
   


3. 
   

   Equipment Qualification and Calibration:

   
   
   
   
   • Conduct equipment qualification (IQ/OQ/PQ/RQ and PV).
   
   
   • Perform calibration activities related to the Microbiology department.
   
   
   
   


4. 
   

   Change Control, Deviation, and CAPA:

   
   
   
   
   • Initiate and manage Change Control, Deviation, and Corrective and Preventive Actions (CAPA).
   
   
   
   


5. 
   

   Bioburden Testing:

   
   
   
   
   • Perform bioburden tests for water, raw materials, and products.
   
   
   
   


6. 
   

   Population Determination of Biological Indicators:

   
   
   
   
   • Conduct population determination of biological indicators.
   
   
   
   


7. 
   

   Cell Bank Testing:

   
   
   
   
   • Perform cell bank testing.
   
   
   
   

Work Experience

5 to 8 year experience 

Education

Competencies