Responsibilities:
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To perform quality control microbiological testing of raw materials, incoming goods, intermediates, in-process, drug substance, and/or finished products under cGMP conditions for QC release or part of stability studies
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To perform monitoring and testing for the facility and utilities system
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To support instrument qualification
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To support equipment qualification e.g., controlled temperature units, isolator, biosafety cabinets
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To perform and coordinate calibration, preventative maintenance and repairs or laboratory instruments/equipment
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To support aseptic process simulations
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To support microbiological method transfer/development/validation/verification/suitability
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To perform periodic review for laboratory documents
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To manage microbiological inventory required for sampling and testing
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To ensure adherence to ALCOA principles for managing laboratory data
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To adhere to site/job role training plan, and maintain individual training records
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To support continuous improvement initiatives
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To maintain laboratory housekeeping using 5S approach
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Ensure timely escalation of investigations accidents, near misses and breaches of policies
To carry out tasks required by the reporting Manager
Education background:
Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent.
Experience:
2-3 years of experience in the pharmaceutical or medical devices industry, with experience on working in a laboratory environment preferred, but fresh graduates with laboratory experience during tertiary studies is acceptable.