QC - Microbiology

Role & responsibilities

• Perform bioburden testing, endotoxin testing (LAL), and sterility testing of raw materials, in-process samples, and finished products.
• Conduct water analysis, including testing for microbial load in purified water, RO water, and WFI.
• Perform growth promotion tests on microbiological media.
• Conduct environmental monitoring in clean rooms (air sampling, surface monitoring, personnel monitoring, and particle count).
• Analyze trends in environmental monitoring data and recommend corrective actions when necessary.
• Maintain accurate records of all tests, procedures, and results in compliance with Good Documentation Practices (GDP).
• Ensure adherence to ISO 13485:2016 and EU-MDR guidelines in all microbiological activities.
• Ensure timely calibration, validation, and maintenance of microbiological testing equipment (e.g., autoclaves, incubators, air samplers, etc.).
• Maintain a clean and sterile laboratory environment.

• Skills:
• Strong knowledge of ISO 13485:2016, EU-MDR, and GMP guidelines.
• Proficiency in microbiological techniques and data interpretation.
• Excellent documentation skills and familiarity with GDP.
• Good communication and teamwork abilities.