Executive
Job Description
• 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.