Microbiologist (FDA Approved)

Role & responsibilities:

1.     Perform routine microbiological testing of raw materials, intermediates, APIs, water samples (Purified Water, RO Water), and environmental monitoring (EM).

2.     Conduct microbial limit testing (MLT), endotoxin (LAL) tests, bioburden testing, and identification of microorganisms.

3.     Perform environmental monitoring activities in cleanrooms including viable and non-viable particle count, swab sampling, and settle plates.

4.     Execute validation activities such as water system validation, cleanroom qualification, disinfectant efficacy studies

5.     Prepare and maintain proper documentation as per GMP, GDP, and regulatory requirements (logbooks, protocols, reports).

6.     Support and ensure compliance during internal and external audits

7.     Maintain and calibrate laboratory instruments like autoclaves, incubators, particle counters, and microscopes.

8.     Follow and enforce safety procedures in the microbiology lab.

9.     To operate and to maintain all equipment in microbiological laboratory, like Calibration, Validation, AMC and Break down.