Key Responsibilities:

• Perform microbiological testing such as sterility testing, bioburden, endotoxin (LAL), and microbial limit tests
• Conduct environmental monitoring (EM) of cleanrooms (air, surface, personnel monitoring)
• Prepare and manage culture media, including growth promotion testing (GPT)
• Handle and maintain microbial cultures and laboratory equipment
• Record, review, and maintain accurate documentation as per GMP requirements
• Investigate OOS (Out of Specification), OOT (Out of Trend), and deviations
• Support validation activities such as method validation, cleaning validation, and media fills
• Ensure compliance with cGMP, GLP, and regulatory standards (USFDA, WHO, etc.)
• Participate in internal and external audits and ensure audit readiness
• Maintain laboratory cleanliness, safety, and proper waste disposal