Microbiologist

• Microbiology tests
• Antimicrobial effectiveness test
• Bacterial Endotoxin test
• Sterility test
• Microbial Limit Test
• Media preparation
• Growth promotion test
• bio-Assay of different antibiotics
• Disinfectant qualification
• Microbial Analysis of RO water and Water for injection
• Environmental monitoring of Control the clean area with USP standard parameters
• non viable count in clean room
• chemical analysis of RO and water for injection
• sterilization and Depyrogenation validation by Control standard Endotoxin
• Microbial limit test (MLT) of non sterile products and Bioburden test of Raw materials and Finished product
• Total organic Carbon
• Liquid particle Counter
• Water for injection Chemical test
• FTIR and HPLC analysis

Description:

• Microbial Testing and Analysis: Conduct microbiological tests on raw materials, in-process samples, and finished products to detect microbial contamination and ensure product safety.
• Quality Control: Implement and monitor quality control procedures to meet regulatory requirements (e.g., USP, EP, ICH) and company standards.
• Sterility Testing: Perform sterility and endotoxin testing to ensure that pharmaceutical products are free of harmful microorganisms.
• Environmental Monitoring: Oversee and conduct environmental monitoring of production areas to ensure compliance with cleanliness and contamination control standards.
• Method Development: Develop and validate new microbiological methods and techniques to improve testing accuracy and efficiency.
• Documentation and Reporting: Maintain accurate records of tests, results, and procedures. Prepare detailed reports and documentation for regulatory compliance and internal quality assurance.
• Troubleshooting: Investigate and resolve microbiological issues related to product quality, production processes, and contamination sources.
• Regulatory Compliance: Ensure all microbiological practices adhere to relevant regulatory guidelines and standards. Assist in preparing for and supporting regulatory inspections and audits.
• Collaboration: Work closely with other departments such as production, quality assurance, and research and development to support cross-functional projects and initiatives.