Senior Scientist - QC Microbiology
Senior
Job Responsibilities:
- 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
- To perform monitoring and testing for the facility and utilities system
- To support instrument qualification
- To support equipment qualification e.g., controlled temperature units, isolator, biosafety cabinets
- To perform and coordinate calibration, preventative maintenance and repairs or laboratory instruments/equipment
- To support aseptic process simulations
- To support microbiological method transfer/development/validation/verification/suitability
- To perform periodic review for laboratory documents
- To manage microbiological inventory required for sampling and testing
- To ensure adherence to ALCOA principles for managing laboratory data
- To adhere to site/job role training plan, and maintain individual training records
- To support continuous improvement initiatives
- To maintain laboratory housekeeping using 5S approach
- Ensure timely escalation of investigations accidents, near misses and breaches of policies
- To carry out tasks required by the reporting Manager
Environmental Monitoring Requirements:
Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent.
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.