• To ensure the timely sampling and testing of purified water, Process and finish product samples. • To ensure timely regeneration and maintenance of the Culture • To ensure the media preparation as per the analysis planning and the effectiveness and sterility of the media to be ensured. • To ensure the aseptic condition of the microbiology testing area to be maintained • To ensure environment monitoring in the powder processing area and microbiology laboratory. Preparation of the trend for the evaluation of the environment condition of the area. • To ensure maximum utilization of laboratory Instruments. • To ensure the lab preparativeness for the regulatory and customer audits. • To ensure the timely purchase of the media ,cultures and other lab regents • To ensure the effective planning of the daily activity of the microbiology lab. • To ensure the every analysis is to be analysed as per predefined specification and method of analysis. • To report any OOS/incidents / Deviation/ discrepancy in laboratory analysis to section in charge /QC In-charge. • Ensure daily on-line entry in LIMS modules. • Ensure the calibration ,operational and validation status of the instruments in the microbiology laboratory • Ensure the timely Qualification / Validation of all instruments in microbiology laboratory. • Co-ordinate with service engineer regarding break-down and preventive maintenance of instruments. • Ensure that all documents / records required for Regulatory Compliance are maintained properly. • To ensure the analytical documents like specification, protocol, STP, are prepared as per SOP. • Ensure all issues related to completed batches are resolved and documents are transferred to QA. • To maintain instruments logbooks properly as per analysis. • To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively. • To ensure the safe disposal of the media and culture waste. • To educate and train the workmen and implement in safe handling of media, reagents, cultures, chemicals, gas cylinder and laboratory instruments to prevent the accidents. • To ensure the storage of lab. Chemicals and test samples at proper place with segregation to prevent accidents. • To coordinate with QA department for cGMP system • To coordinate with production department for planning/clubbing of analysis.
