Executive

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