Perform routine and non-routine microbiological testing of pharmaceutical products, water systems, and environmental monitoring samples according to GMP and company SOPs.
Conduct endotoxin testing for raw materials, bulk products, and final drug formulations.
Carry out bioburden testing to assess the microbial load in drug substances, water samples, and production components.
Execute sterility testing using direct inoculation or membrane filtration methods
Support the Sterility Assurance Program through risk-based contamination control strategies, cleanroom monitoring, and aseptic process simulations (media fills).
Perform microbial identification using classical and rapid microbiological methods.
Ensure strict adherence to cGMP, aseptic techniques, and data integrity requirements.
Document all work accurately and in compliance with laboratory standards and regulatory expectations.
Investigate out-of-specification (OOS) results and support root cause analysis and CAPA development.
Participate in environmental and utility monitoring programs for manufacturing cleanrooms, including air, surface, and personnel monitoring.
Assist in validation of microbiological test methods and qualification of laboratory equipment.
Contribute to audits, inspections, and continuous improvement initiatives within the QC Microbiology laboratory.
Qualifications:
Bachelor’s or Master’s degree in Microbiology, Biology, or a related field.
Minimum of 2-3 years of experience in a microbiology laboratory, preferably within the pharmaceutical or biotech industry.
Strong knowledge of GMP, FDA, and other regulatory guidelines for pharmaceutical manufacturing.
Hands-on experience with microbiological testing techniques, including sterility, endotoxin, and microbial identification.
Familiarity with aseptic techniques and cleanroom environments.
Proficient in the use of microbiological laboratory equipment (e.g., autoclaves, incubators, laminar flow hoods).
