JOB SUMMARY
Staff- QC Microbiology is responsible for the following technical and administrative work such as checking, receiving and registration of samples, sorting of samples to the test areas, tests carried out are according to the method specified, results are precise and accurate, and tests are completed as per sample priority and due date, accurate data entry, generating the reports, and timely delivery of results and reports, without compromising on the quality, accuracy and procedures. Assist senior staff in method validation and method development.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Checking, receiving and registration of samples, sorting samples to the test areas.
· Able to perform review of all worksheets and logbooks.
· Assist senior staff for the execution of method validations, qualifications, and transfers.
· Perform microbiology analysis (Bioburden, Endotoxin, Sterility, Biological Indicator, Identification, and Environmental Monitoring, etc.) under the direction of senior staff with compliance to the procedures and standards, with timely delivery as per sample priority or due date, without compromising the quality and accuracy.
· Able to perform other testing upon completion training of test methods and Verification of Effectiveness (VOE) of QC Chemistry and QC Function Team.
· Maintain filing records as per record management retention schedule by filing the worksheets, shredding expired records to ensure that there are no expired records maintained.
· Conduct supporting duties such as wash and dry apparatus and vials and reject and discard samples.
· Support in inventory of spares, gases, chemicals, consumables etc. to ensure no incidence of zero stock level.
· Prepare testing samples, solutions, standards and reagents to support testing.
· Adhere to all safety regulations and practices conforming to EHS regulations.
· Assist with Lab OOS/NC/CAPA Investigations in his/ her area.
· Practice 5S and conduct self- audit as per sectional audit checklist.
· Record any verifications, maintenance and calibration or repair works in the respective equipment logbook.
· Follow Good Manufacturing Practices (cGMP) as well as all safety regulations and company procedures.
